Document Generator Library

Use this SOP Performance Evaluation template to systematically document and manage the evaluation of your in vitro diagnostic (IVD) device’s scientific validity, analytical performance, and clinical performance in compliance with IVDR Article 56 and Annex XIII. This template is essential for demonstrating conformity with relevant safety and performance requirements and should be completed during product development and updated continuously with post-market data. Completing this SOP ensures robust clinical evidence and supports your device’s technical documentation for regulatory submissions and ongoing compliance.

Use this Shelf-life Verification Guide template to plan and document the necessary testing for medical device shelf-life claims, covering both accelerated and real-time aging methods to ensure packaging and device integrity over the intended storage period. Complete this guide before engaging a contract laboratory, as it helps define the testing approach, intervals, and required outcomes for regulatory compliance. Fill out this document when you need to establish or validate the expiration date of your medical device as part of your technical documentation or regulatory submission.

Use this SOP Feedback and Complaint Management template to systematically document, classify, and resolve feedback and customer complaints related to your medical device products. This template is essential for regulatory compliance, ensuring all feedback—including customer complaints, support requests, and negative product events—is properly monitored, evaluated, and recorded; it should be filled out whenever feedback is received from any source, especially after product release. Completing this SOP supports post-market surveillance, risk management, and continuous product improvement, meeting key requirements under MDR/IVDR, ISO 13485, and IEC 62304.

Use this Usability Evaluation Report template to systematically document the results of formative and summative usability testing for your medical device user interface, ensuring compliance with IEC 62366-1:2015 and regulatory expectations. This report is essential for capturing design feedback, user testing outcomes, and the impact on device safety, and should be completed following usability evaluations during the development process and prior to regulatory submission.

Use this Verification and Validation (V&V) Plan template to systematically document and organize all planned verification and validation activities for your medical device, including hardware, software, packaging, shipping, electrical safety, and biocompatibility testing. This template is essential for demonstrating compliance with regulatory requirements and industry standards during design and development, and should be filled out prior to initiating V&V testing to ensure all protocols, responsibilities, and acceptance criteria are clearly defined and approved. Completing this document provides a comprehensive foundation for regulatory submissions and quality audits by ensuring every aspect of product testing and validation is planned and traceable.

Use this User Needs List template to clearly document and organize the specific needs and expectations of users for your medical device, which is essential for guiding product development, design inputs, and ensuring regulatory compliance with ISO 13485 and IEC 62366-1. Complete this template early in the design control process to provide a solid foundation for usability engineering, risk management, and conformity with EU MDR requirements.

Use this Technical File template for standalone medical device software to systematically document all required information for EU MDR and FDA compliance, including device description, intended use, risk management, design and development, software verification and validation, clinical evaluation, and post-market surveillance. Completing this template is essential prior to device submission or regulatory audit, as it ensures your technical documentation is comprehensive, traceable, and aligns with medical device regulatory requirements. This document is crucial for demonstrating conformity, supporting regulatory submissions, and facilitating Notified Body or FDA review of your software medical device.

Use this Usability Evaluation Plan template to systematically organize and document your planned usability testing activities, including formative and summative evaluations, for medical devices prior to market release as required by IEC 62366-1:2015 and risk management processes. Complete this plan during the product development phase to ensure all user interface hazards and critical tasks are identified, evaluated, and mitigated, supporting regulatory human factors engineering requirements.

Use this Traceability Matrix template to systematically link regulatory, design, and development requirements to corresponding outputs, such as risk management activities, testing, and verification/validation results for your medical device. This document is essential for demonstrating compliance with ISO 13485 and ISO 14971 and should be completed throughout the product development lifecycle to ensure all requirements are addressed and properly documented for regulatory submissions and audits.

Use this Training Log template to systematically document employee training activities, ensuring compliance with medical device quality system requirements. This record is essential for tracking individual training histories, demonstrating competency, and should be completed each time an employee undergoes relevant training related to their role or regulatory obligations. Properly maintaining this log supports audit readiness and regulatory inspections.

Use this Usability Evaluation Protocol template to systematically plan and document your medical device user interface summative usability testing, focusing on critical and hazard-related use scenarios as required by IEC 62366-1:2015. This protocol ensures that all necessary user tests are outlined, tracked, and evaluated, supporting your risk management and design verification processes. Complete this document before conducting usability testing to demonstrate compliance and capture essential data for your Usability Evaluation Report.

Use this UDI Details template to document your device’s Unique Device Identification (UDI) information, including UDI-DI, UDI-PI, SRN, and EMDN code, as required for regulatory submissions and product traceability. Completing this template is essential when preparing technical documentation, registering your medical device, or updating regulatory databases to ensure compliance with EU MDR and global UDI requirements.

Use this Supplier Qualification Checklist template to systematically evaluate and document the suitability of potential or previously blocked suppliers before adding them to your Approved Supplier List. Completing this checklist is essential for ensuring compliance with medical device quality management requirements, as it helps you assess supplier performance, assign approval status, and identify any necessary surveillance measures. Fill out this document during initial supplier qualification or when reconsidering a blocked supplier to maintain a robust and compliant supply chain.

Use this Subsystem Requirements List template to clearly document and manage specific subsystem requirements for your medical device, ensuring traceability and regulatory compliance. Complete this document during the design and development phase to define subsystem functions and associated risk controls, supporting both design verification and risk management activities. This template is essential for demonstrating structured subsystem planning to meet quality and regulatory standards.

Use this System Requirements List template to clearly define and document all essential system-level requirements for your medical device, ensuring comprehensive traceability and compliance throughout the product development lifecycle. This template should be completed at the early stages of development to guide design, testing, and regulatory submissions, forming the foundation for more detailed subsystem requirements. Properly documenting system requirements is crucial for demonstrating regulatory compliance and aligning stakeholder expectations.

Use this Software Validation Form template to systematically document the validation process for software used in quality management or production of medical devices, ensuring compliance with regulatory requirements. Complete this form whenever you implement, update, or assess software that could impact device quality, performance, or regulatory compliance, as it guides you through risk assessment, validation planning, testing, and ongoing monitoring. This template is essential for demonstrating that your software is fit for its intended use and that risks are effectively managed and controlled.

Use this Software System Test Report template to document and summarize the results of your software system testing, ensuring all software requirements have been verified according to your development and maintenance plan. This report is essential for demonstrating compliance during design verification and must be completed and reviewed before releasing your medical device software. Properly filling out this template supports regulatory submissions and audits by providing evidence of resolved or justified test failures.

Use this Software Development and Maintenance Plan template to document and control all activities related to the development, maintenance, version control, verification, and validation of medical device software in compliance with IEC 62304 and ISO 13485. This template is essential for ensuring traceability, managing software changes, and meeting regulatory requirements throughout the software lifecycle, and should be completed at the start of software development and updated as the software evolves. It helps you organize responsibilities, document key deliverables, and ensure risk management—including SOUP evaluation—for each development stage.

Use this Software System Test Plan template to systematically verify that your medical device software meets all defined requirements before release. This document is essential for planning and documenting comprehensive system-level testing, ensuring regulatory compliance, and should be completed during the final stages of software development prior to generating the system test report. Filling out this template helps you identify and address any test failures, supporting a robust validation process for FDA and EU MDR submissions.

Use this Software of Unknown Provenance (SOUP) List template to systematically document all third-party or legacy software components incorporated into your medical device, detailing their associated risks, requirements, and placement within your software architecture. Completing this template is essential during software development and risk management activities to ensure regulatory compliance, facilitate risk assessments, and support traceability of SOUP components throughout the device lifecycle.

Use this Software Release Checklist template to ensure all required documentation and validation processes are completed before releasing a new software version for medical devices. This checklist is essential for compliance with IEC 62304 and internal SOPs, and it should be filled out as a final step prior to product launch or distribution to demonstrate regulatory readiness and quality assurance.

Use this SOP Usability Engineering template to systematically manage all usability engineering activities for your medical device, from user research and requirements gathering to formative and summative usability testing and post-market monitoring. Completing this SOP is essential for demonstrating compliance with IEC 62366-1 and FDA usability guidance, and it should be filled out throughout the design, development, verification, and post-market phases to ensure user needs, safety, and regulatory requirements are consistently met.

Use this SOP Vigilance template to guide the identification, investigation, documentation, and reporting of serious incidents and field safety corrective actions (FSCA) for medical devices, ensuring compliance with EU vigilance reporting requirements. Complete this document whenever a potential or confirmed serious incident, FSCA, or related safety concern arises, to fulfill mandatory timelines for notifying competent authorities and maintaining a robust quality management system. This SOP is essential for timely regulatory reporting, risk mitigation, and maintaining product safety in the post-market phase.

Use this Software Architecture template to document the structural design and interconnections of your medical device software in compliance with IEC 62304. You should complete this template during the design and development phase to clearly define software items, their relationships, security measures, and system requirements, ensuring alignment with regulatory expectations and facilitating clear communication among development and regulatory teams. This document is essential for traceability, risk management, and future modifications or audits.

Use this SOP Statistical Methods template to standardize and document your approach to statistical techniques, sampling plans, and data analysis for product development, process validation, and quality assurance activities. This template is essential for ensuring regulatory compliance, supporting risk-based decision-making, and justifying sample sizes and statistical methods during design verification, process capability studies, and supplier evaluations. Complete this SOP when implementing or revising statistical methods as part of your quality management system or prior to conducting verification, validation, or ongoing production monitoring.

Use this SOP Software Development template to establish a compliant, structured process for developing medical device software in line with IEC 62304 and IEC 62366 requirements. This document is essential for ensuring software safety, performance, risk management, and usability, and should be completed and maintained for each new software project or when significant changes are made. Fill out this template to guide your team through all required software development lifecycle stages, support regulatory submissions, and maintain robust technical documentation for audits and product approvals.

Use this SOP Software Problem Resolution template to systematically document, investigate, and resolve software issues for your medical device products, both before and after market release. Filling out this template is essential whenever a software problem is identified—whether during development, from user feedback, or post-market surveillance—to ensure compliance with ISO 62304 requirements and maintain device safety, performance, and regulatory traceability. This process helps you track problem reports, conduct root cause analysis, implement corrective actions, and update risk management files as needed.

Use this SOP Risk Management template to guide your systematic approach for identifying, assessing, controlling, and monitoring risks throughout the entire lifecycle of your medical device, in alignment with ISO 14971:2019 and relevant regulatory requirements. Complete this document during all key phases—from design and development to post-market production—to ensure comprehensive risk management, support product safety, and maintain regulatory compliance. This template is essential for documenting risk management files, plans, assessments, mitigation actions, and ongoing post-market risk evaluations.

Use this SOP Sales template to ensure your medical device sales and marketing activities comply with regional regulatory requirements, including claim substantiation, product eligibility, and necessary qualifications for specialized markets like Germany. Complete this document prior to offering or selling any medical device to verify that all marketing materials, contracts, and sales practices align with applicable laws and standards, helping you maintain regulatory compliance and avoid enforcement risks. This template is essential for medical device manufacturers and distributors to manage compliant sales processes and documentation.

Use this SOP template to systematically identify, document, evaluate, and manage nonconformances in hardware and software medical devices during manufacturing, testing, or inspection. Completing this document is essential whenever a product or process deviates from specified requirements, ensuring regulatory compliance, product safety, and traceability of corrective actions. This template helps you fulfill ISO 13485, FDA 21 CFR 820, and EU MDR requirements for controlling nonconforming products and processes.

Use this SOP Regulatory Strategy template to define and document your organization’s approach for bringing medical devices to the US and EU markets, covering device classification, regulatory pathways (such as FDA 510(k), PMA, CE Marking), pre-market, and post-market requirements. Complete and maintain this SOP to ensure regulatory compliance, address evolving requirements, and manage the impact of regulatory changes on your products and processes throughout the device lifecycle. This template is essential for regulatory, quality, and product teams and should be filled out and updated before market entry and whenever relevant regulations are updated.

Use this SOP Product Registration and Certification template to systematically guide your team through the medical device registration, certification, and UDI creation process for both EU and US markets. This document ensures compliance with all technical documentation, conformity assessment, and declaration of conformity requirements, and should be completed whenever a new or updated medical device is being prepared for market release. It is essential for maintaining regulatory compliance and market access, and must be filled out prior to product launch to document all required steps and responsibilities.

Use this SOP Post-Market Surveillance template to establish, document, and maintain your medical device post-market surveillance processes, ensuring systematic collection and analysis of safety, performance, and quality data for devices placed on the EU market. You should complete this template when your devices are commercially available, to define and manage PMS plans, reports (PMSR, PSUR), and trend analysis activities required for ongoing regulatory compliance, risk management, and improvement actions. This SOP is crucial for meeting EU MDR/IVDR requirements and demonstrating proactive vigilance throughout your product’s lifecycle.

Use this SOP Computer System Validation template to guide the systematic validation of software and computer systems that impact your medical device quality management system or critical production processes. This document is essential for ensuring regulatory compliance (such as ISO 13485, GAMP5, 21 CFR Part 11, MDR/IVDR) and should be completed whenever new software is implemented, updated, or decommissioned to document risk-based validation planning, testing, deployment, maintenance, and retirement activities. Proper use of this SOP helps maintain data integrity, product safety, and continuous regulatory compliance throughout your software lifecycle.

Use this Periodic Safety Update Report (PSUR) template to systematically document and analyze the post-market safety, performance, and risk-benefit profile of your medical device, as required for EU MDR compliance. Complete this template at the specified intervals (annually or biennially, depending on device class) to summarize sales, incidents, corrective actions, complaints, literature review, and post-market clinical follow-up, ensuring proactive identification and management of safety concerns. This report is crucial for demonstrating ongoing device safety and performance to notified bodies and regulatory authorities.

Use this SOP Manufacturing template to establish a standardized process for transferring medical device designs and manufacturing activities between sites or from design to manufacturing. It is essential for ensuring regulatory compliance, product quality, and clear team responsibilities during manufacturing transfer, and should be completed whenever a product is moved to a new manufacturing location or introduced for initial production. This document is crucial for maintaining robust documentation, supporting regulatory submissions, and mitigating risks during manufacturing transitions.

Use this SOP Management Review template to systematically document and conduct your organization's annual quality management system (QMS) review, ensuring compliance with ISO 13485:2016 and relevant regulatory requirements. This template guides you through collecting key performance indicators, analyzing QMS effectiveness, and documenting management review outcomes—essential before audits or when significant changes affect your QMS. Completing this document helps you identify opportunities for improvement, fulfill regulatory obligations, and demonstrate ongoing QMS suitability and effectiveness.

Use this SOP Internal Audit template to establish a consistent, compliant process for planning, conducting, and documenting internal audits of your quality management system, including required auditor qualifications and handling of findings such as nonconformities and opportunities for improvement. This document is essential for demonstrating ongoing compliance with ISO 13485, FDA QSR, and EU MDR/IVDR requirements, and should be completed whenever you plan or perform internal audits to ensure your processes meet regulatory and organizational standards. Filling out this template helps you identify gaps, drive continuous improvement, and prepare for external audits or inspections.

Use this SOP Human Resources and Training template to systematically document and manage employee competence, training, and qualification requirements in your medical device company, ensuring compliance with ISO 13485, FDA 21 CFR 820, and EU MDR/IVDR regulations. Complete this template when onboarding new staff, updating roles, or implementing new or revised processes to maintain thorough training records, verify employee readiness, and support effective performance reviews. This is essential for demonstrating regulatory compliance and maintaining high product quality standards.

Use this SOP Document and Record Control template to establish standardized procedures for creating, reviewing, approving, labeling, and archiving quality management system documents and records throughout your medical device organization. This template is essential for ensuring regulatory compliance, document traceability, and secure retention, and should be filled out when implementing or updating document control processes, especially prior to audits or regulatory submissions. Proper use of this template helps you maintain up-to-date, accessible, and auditable documentation as required by ISO 13485, FDA 21 CFR Part 820, and EU MDR/IVDR.

Use this SOP Design Control template to guide your hardware and system medical device design and development process, ensuring you meet regulatory requirements and create safe, effective products. Complete this template for each device project from initial concept through post-market monitoring to maintain compliance, manage risk, and provide clear documentation for regulatory submissions and audits. This SOP is essential for structured product development, traceability, and quality assurance throughout the device lifecycle.

Use this SOP Deployment template to document and control the production, deployment, installation, integration, and updates of medical devices into customer environments, ensuring compliance with ISO 13485, FDA 21 CFR 820, EU MDR, or IVDR requirements. Fill out this template whenever you build, release, or update a medical device to ensure proper infrastructure qualification, traceability, monitoring, and user training, thereby maintaining device safety, performance, and regulatory compliance throughout its lifecycle. This is essential for manufacturers to standardize deployment processes, reduce risks, and demonstrate conformity during audits or inspections.

Use this SOP Corrective and Preventive Action (CAPA) template to systematically document, implement, and track actions taken to address and prevent actual or potential quality issues and nonconformities in your medical device processes, products, or services. This template is essential for meeting key ISO 13485, FDA 21 CFR 820.100, and MDR/IVDR requirements, and should be filled out whenever nonconformities, audit findings, customer complaints, or other significant quality events arise that require root cause analysis and long-term resolution. Completing this SOP ensures regulatory compliance, supports continuous improvement, and helps maintain the safety and effectiveness of your medical devices.

Use this SOP Cybersecurity template to establish and document your processes for identifying, mitigating, and managing cybersecurity risks in Software as a Medical Device (SaMD) and Software in a Medical Device (SimD) throughout their lifecycle, as required by regulatory standards. Complete this SOP during the design, development, premarket submission, and postmarket surveillance phases to ensure compliance with FDA, EU MDR, or IVDR cybersecurity requirements and industry best practices, thereby safeguarding patient safety and device functionality.

Use this SOP Clinical Evaluation template to systematically plan, conduct, and document the clinical evaluation process for your medical device, ensuring compliance with EU MDR 2017/745 and related guidance. This document is essential when bringing new products to market, updating clinical evidence, or responding to significant product or safety changes, and helps you demonstrate and maintain the required safety, performance, and benefit-risk evidence throughout the device lifecycle. Fill it out as part of your technical documentation to support conformity assessment and ongoing post-market surveillance activities.

Use this SOP Change Management template to systematically document, evaluate, approve, and implement changes to released medical devices or quality management systems, ensuring ongoing regulatory compliance and product safety. Complete this template whenever you need to process product modifications, bug fixes, or organizational updates, especially when changes could impact risk management, technical documentation, or require notification to users and regulatory authorities. This process is essential for maintaining ISO 13485, EU MDR/IVDR, and FDA 21 CFR 820 compliance and should be initiated promptly upon identifying any necessary post-market changes.

This Risk Management Plan outlines the policies and processes for identifying, evaluating, and mitigating risks associated with your device during its development and post-market phase. It ensures that safety standards and regulatory requirements are met, minimizing potential harm to users.

Use this Risk Management Report template to document the summary and outcomes of your medical device risk management activities, demonstrating compliance with ISO 14971:2019 requirements. You should complete this report after executing your risk management plan, to confirm all identified risks have been addressed, appropriate risk control measures implemented, and the overall benefit-risk profile evaluated. This document is essential for regulatory submissions and audits, ensuring traceability and justification of risk-related decisions throughout the product lifecycle.

Use this Risk Management Plan template to systematically document your medical device’s risk policy, acceptance criteria, and risk management activities in alignment with ISO 14971 and FDA requirements. Complete this document at the beginning of product development and update it throughout the lifecycle to ensure all risks are identified, evaluated, controlled, and monitored, supporting regulatory compliance and patient safety. This template is essential for demonstrating a structured, compliant approach to risk management and is required for regulatory submissions and audits.

Use this Risk Assessment template to systematically identify, analyze, and control potential hazards associated with your medical device, as required by ISO 14971:2019. Complete this document during product development and whenever significant changes occur, to ensure that all risks—such as software, usability, and cybersecurity—are addressed, mitigated, and documented for regulatory compliance. This template is essential for demonstrating risk management and residual risk acceptability in your device’s technical documentation.

Use this Release Notes template to clearly document and communicate all updates, changes, and bug fixes for your medical device software version. This template is essential for regulatory compliance, traceability, and quality management, and should be filled out and distributed every time a new software version or update is released. Keeping accurate release notes helps ensure transparency for auditors, regulatory bodies, and end users.

This document details the risk assessment for your device, adhering to ISO 14971:2019 standards. It identifies potential hazards, evaluates risks, and outlines mitigation measures to ensure safety and compliance throughout the product development process.

Use this Required Documentation Training by Functional Group template to ensure employees receive proper training on relevant SOPs when they start a new role or when processes are updated. This document helps you track and assign SOP training by functional group, supporting regulatory compliance and quality management system requirements. Complete this template during onboarding and whenever SOPs are revised to maintain up-to-date training records for ISO 13485, EU MDR, and FDA QSR compliance.

Use this Quality Manual template to define and communicate your organization’s Quality Management System (QMS) structure, quality policy, objectives, and key processes as required by ISO 13485 and related medical device standards. This document is essential for demonstrating regulatory compliance, establishing company-wide quality expectations, and should be completed and maintained as a foundational step in your QMS implementation or certification process.

Use this Post-Market Surveillance Report template to systematically collect, analyze, and summarize safety and performance data for your medical device after it has been placed on the market. Completing this report is essential every two years (or as requested by a notified body) to document vigilance data, complaints, incidents, and trend analyses, ensuring ongoing regulatory compliance and proactively identifying risks or needed improvements to your device. This template helps you fulfill EU MDR Article 84 and related requirements by providing structured evidence of your device’s post-market safety and performance.

Use this Post-Market Surveillance (PMS) Plan template to systematically outline how you will collect, analyze, and report safety and performance data for your medical device after it has been placed on the market. This document is essential for meeting EU MDR and FDA requirements, guiding you on vigilance data sources, complaint handling, trend analysis, and corrective actions, and should be filled out before product launch and regularly updated during the device’s lifecycle. Completing this plan ensures you proactively identify and address risks, maintain regulatory compliance, and provide the necessary input for your PMS or PSUR reports.

Use this Post-Market Clinical Follow-Up (PMCF) Evaluation Report template to systematically document and analyze the results of all PMCF activities performed for your medical device, as required by EU MDR. This report is essential for demonstrating ongoing clinical performance, safety, and risk management, and should be completed following the execution of your PMCF plan or when significant new clinical data becomes available. Properly filling out this report supports regulatory compliance and helps maintain your device’s CE mark.

Use this Post-Market Clinical Follow-Up (PMCF) Plan template to systematically outline your planned activities for ongoing clinical data collection and safety monitoring of your medical device after it enters the market. Completing this document is essential for demonstrating continued device safety, performance, and benefit-risk acceptability, and should be filled out prior to or upon market launch, with updates as new post-market data or risks emerge. This template ensures you meet EU MDR requirements for proactive post-market surveillance and provides a structured approach for regulatory compliance and technical documentation.

Use this Packaging and Shelf-life Design template to document the packaging specifications, shelf-life, and storage conditions for your medical device, ensuring compliance with regulatory requirements for product safety and integrity. Complete this template during the design and development process to demonstrate that your device’s packaging and shelf-life have been properly defined and justified for regulatory submissions and audits. This is essential for showing how your device remains safe and effective throughout its intended shelf-life and distribution.

Use this List of Regulatory Requirements template to systematically capture and track all relevant regulations and standards that apply to your medical device. Completing this document is essential during product development and throughout the device lifecycle to ensure comprehensive compliance, support regulatory submissions, and demonstrate ongoing adherence to both EU MDR and US FDA requirements.

Use this Mechanical Design template to comprehensively document the design, material selection, and assembly specifications for the physical components of your medical device. Completing this document is essential during the device design and development phase to ensure compliance with regulatory mechanical requirements and to provide clear instructions for manufacturing and verification. Fill out this template when detailing or updating the mechanical aspects of your device to facilitate design reviews, risk management, and regulatory submissions.

Use this List of Medical Devices template to systematically document current and previous versions of your medical devices, including key details like device name, version, release date, unique identifiers, and market availability. This record is essential for regulatory submissions, audits, and lifecycle management, and should be updated whenever a new device version is released or when entering new markets. Maintaining this list helps ensure compliance with traceability and documentation requirements for medical device manufacturers.

Use this Management Review Report template to document and evaluate the effectiveness, suitability, and adequacy of your quality management system (QMS) by summarizing key performance indicators and compliance status. This report is essential for regulatory compliance and continuous improvement, and should be filled out at least annually or following significant changes to your QMS, as part of your management review process. Completing this template helps demonstrate ongoing oversight and commitment to quality for audits and regulatory inspections.

Use this MDR Classification Document template to determine and justify the correct classification of your medical device according to EU MDR 2017/745 Annex VIII rules. This document is essential for regulatory submissions and must be completed during the design and development phase—before engaging with notified bodies—to ensure your device is accurately categorized and compliant with EU regulatory requirements.

Use this List of Validated Software template to document all software applications that have been formally validated for use in your organization's quality management, production, or servicing processes. This list is crucial for regulatory compliance, demonstrating control over electronic systems, and should be updated and reviewed whenever new software is implemented or existing software is modified.

Use this “List of Known Anomalies” template to document any unresolved software bugs or residual issues that will remain in the released version of your medical device software. Completing this is essential for compliance with IEC 62304, and it should be filled out before software release to ensure transparency and risk management for both regulatory submissions and internal quality assurance.

Use this "List of CAPAs" template to efficiently track and document all implemented Corrective and Preventive Actions within your quality management system, supporting compliance with ISO 13485, EU MDR, and FDA 21 CFR 820 requirements. You should maintain and update this list whenever a new CAPA is initiated or completed to ensure transparent oversight and facilitate audits or inspections. This tool helps you demonstrate ongoing quality improvement and effective issue resolution in your medical device processes.

Use this Interface Design template to clearly document and define all interface specifications and connections for your medical device, ensuring seamless integration and interoperability between components. This template is essential for development and regulatory submissions, and should be completed during the device design phase to demonstrate how different parts of your device interact safely and effectively. Properly documenting interfaces supports compliance, risk management, and future updates or modifications.

Use this Instructions for Use (IFU) template to provide essential, compliant guidance on the safe and effective use, installation, and maintenance of your medical device, including details on intended use, indications, warnings, and troubleshooting. This document is required to accompany your device at release and must be updated whenever there are significant changes to the product, ensuring users and regulatory bodies have up-to-date information for safety and performance. Properly completed IFUs are critical for meeting regulatory requirements, reducing user error, and supporting product registration in the EU and US markets.

Use this Intended Use template to clearly define your medical device’s purpose, indications, contraindications, target patient population, users, and environments, as required by EU MDR Annex II and relevant ISO/IEC standards. Completing this document is essential early in product development and for regulatory submissions, as it establishes the foundation for your risk management, clinical evaluation, and usability engineering documentation. Fill it out to ensure regulatory compliance and to provide clarity for all stakeholders regarding your device’s intended application and limitations.

Use this Incident Assessment Form template to systematically evaluate whether a device-related event qualifies as a serious and reportable incident under medical device vigilance requirements. This form is essential for documenting the assessment, supporting compliance with EU MDR Article 87 and ISO 13485:2016, and should be completed whenever an adverse event or potential safety issue involving a medical device occurs. Completing this form ensures proper investigation, recordkeeping, and reporting to competent authorities when required, helping you maintain regulatory compliance and patient safety.

Use this IVDR Classification Document template to systematically determine and justify the classification of your in vitro diagnostic medical device under EU IVDR 2017/746 Annex VIII rules. Completing this template is essential during the early stages of device development and regulatory submission, as it ensures accurate device classification, which directly impacts conformity assessment routes and regulatory requirements.

Use this MDR General Safety and Performance Requirements (GSPR) checklist template to systematically demonstrate and document your medical device’s compliance with all applicable EU MDR 2017/745 Annex I requirements. This comprehensive tool guides you in mapping each GSPR to applicable standards, evidence of conformity, and justifications for any deviations, ensuring you address safety, performance, usability, risk management, and labeling requirements. Complete this checklist during CE marking preparation or significant design changes to support your technical documentation and facilitate a smooth conformity assessment with Notified Bodies.

Use this medical device label template to ensure your product packaging and documentation meet EU MDR 2017/745 labeling requirements, including CE marking, UDI, manufacturer information, and software release details. This template is essential for regulatory compliance and must be completed before placing your device on the EU market to provide clear identification, traceability, and usage instructions for end users and authorities.

Use this FDA Predicate Device template to clearly document the predicate and reference devices your product is being compared to for substantial equivalence in a 510(k) submission. This form is essential for demonstrating how your device aligns with legally marketed devices, and should be completed during the regulatory preparation phase prior to FDA submission. Proper completion helps streamline your FDA review process and ensures all required predicate details are readily available.

Use this Firmware Design template to document the detailed design and specifications of your medical device's firmware, ensuring clear and traceable firmware requirements and architecture. This document is essential for regulatory submissions, design reviews, and development, and should be completed during the design and development phase to demonstrate compliance with medical device software and firmware standards.

Use this Field Safety Notice (FSN) template to quickly communicate urgent safety information, risks, and necessary actions related to a specific medical device to healthcare professionals and relevant stakeholders. This document is essential for regulatory compliance in the event of field corrective actions, recalls, or serious incidents, and should be completed immediately when a device poses a potential or confirmed risk to patient or user safety.

Use this Electrical Design template to clearly document the design, specifications, and schematics of your medical device’s electrical components, ensuring compliance with regulatory requirements and design traceability. Fill out this template during the development phase to provide detailed information on circuit schematics, PCB layouts, and assembly instructions, which are essential for design reviews, risk analysis, and technical documentation submissions. This structured approach helps you streamline regulatory audits and maintain a thorough design history file for your device.

Use this Complaint Log template to systematically record and track all product complaints, adverse events, and relevant customer feedback, as required by your complaint handling procedures. This document is essential for compliance with medical device post-market surveillance and vigilance requirements, and should be filled out promptly whenever a complaint or negative event is reported for your device. Accurate completion of this log supports regulatory reporting, risk management, and continuous product improvement.

Use this EU Declaration of Conformity template to formally declare that your medical device complies with the requirements of the EU Medical Device Regulation (MDR) 2017/745. This document is essential for CE marking and must be completed before placing your device on the European market, serving as proof of conformity and a key part of your technical documentation during audits and regulatory submissions.

Use this Clinical Evaluation Report (CER) template to systematically document and assess the clinical evidence supporting your medical device’s safety, performance, and clinical benefits, as required by EU MDR 2017/745. You should complete this template during the pre-market and post-market phases to demonstrate conformity with regulatory expectations, substantiate clinical claims, and ensure ongoing compliance through literature review, risk analysis, and post-market surveillance. This document is essential for regulatory submissions, audits, and maintaining CE mark certification.

Use this Deployment Evaluation Checklist template to systematically document and assess the installation and deployment process of your medical device, ensuring all infrastructure, monitoring, and product release criteria are met. This checklist is essential for verifying successful and compliant deployment, especially when dealing with complex infrastructures, and should be filled out during each new device installation or significant update. It helps you demonstrate regulatory compliance, track deployment outcomes, and ensure product safety and performance in the field.

Use this Design Review Checklist template to ensure all design inputs for your medical device are thoroughly verified against user needs and regulatory requirements. Complete this checklist at each design review milestone to document compliance, identify gaps, and support your design validation process for both software and physical products. This tool is essential for maintaining quality assurance and meeting regulatory expectations during product development.

Use this Clinical Evaluation Plan template to systematically outline your strategy for collecting, appraising, and analyzing clinical evidence supporting the safety and performance of your medical device, as required for CE marking under EU MDR. Complete this document before initiating or updating your Clinical Evaluation Report to ensure all regulatory, clinical claims, literature review, and post-market data requirements are addressed and clearly documented for notified body submission or internal compliance.

Use this Biological Evaluation Plan template to systematically identify and document the necessary biocompatibility and biological safety tests for your medical device in accordance with ISO 10993-1. Complete this plan early in the product development process—especially for devices with patient or user contact—to ensure that all relevant biological risks are assessed and that appropriate testing strategies are established for regulatory compliance. This template is essential for guiding biological risk assessment and supporting your technical documentation for CE marking or FDA submissions.

Use this Change Request template to formally document and initiate modifications to already released medical devices, ensuring all proposed changes are assessed and approved by the product, quality, and business teams. This form is essential for maintaining compliance with change management procedures and should be filled out whenever you need to propose, evaluate, or track product or process changes. Proper completion supports regulatory requirements, traceability, and risk management throughout the product lifecycle.

Use this Change Evaluation Report template to systematically assess and document the impact, verification, and significance of any change requests made to your medical device or quality system. Completing this report is essential for compliance with change management procedures, helping you determine regulatory notification requirements and ensuring all relevant stakeholders are informed whenever a change is approved and implemented. Fill out this template each time a change request is initiated to maintain clear records and support regulatory audits.

Use this Audit Program template to plan, schedule, and document your organization's internal audit activities, ensuring comprehensive coverage of your quality management system and compliance with regulatory requirements. Fill out this template before starting your audit cycle and update it after each audit to track completed processes and maintain readiness for inspections or certification audits. This tool is essential for demonstrating ongoing internal audit effectiveness and supporting regulatory compliance under ISO 13485, EU MDR, and FDA QSR.

Use this CAPA Report template to systematically document the implementation, actions taken, and effectiveness verification of your corrective and preventive actions in compliance with quality management requirements. Fill out this report after executing your CAPA plan, ensuring all relevant details and outcomes are recorded before closure and entry into your CAPA log. This template is essential for demonstrating regulatory compliance during audits and for maintaining robust quality assurance in your medical device processes.

Use this CAPA Plan template to systematically document, assess, and manage corrective and preventive actions for quality issues in your medical device processes. This form guides you through scoring and qualifying incidents, defining action plans, and evaluating their impact on product safety, performance, and regulatory compliance. Complete this template whenever a significant quality event occurs that may require formal CAPA initiation, ensuring traceability and compliance with your internal SOPs and regulatory expectations.

Use this Audit Plan Template to systematically organize and document your internal or supplier audit activities, participants, and audit scope for medical device quality management systems. This template ensures all required audit criteria and responsibilities are clearly defined and should be completed before each scheduled audit to comply with ISO 13485, EU MDR, or FDA QSR requirements. Properly filling out this template supports effective audit preparation, traceability, and regulatory compliance.

Use this Audit Report template to systematically document and summarize the outcomes of your internal or external quality management system audits, including identified nonconformities and recommendations. Completing this report is essential after each audit to ensure regulatory compliance, facilitate corrective actions, and provide clear evidence of ongoing process monitoring for ISO 13485, EU MDR, or FDA QSR requirements. This template helps you track audit findings, support continuous improvement, and demonstrate due diligence during inspections or certification reviews.

Use this Approved Supplier List template to document and manage all suppliers that have passed your company’s supplier qualification process, ensuring compliance with quality management and purchasing controls. You should complete and regularly update this list to maintain traceability and demonstrate due diligence in supplier selection for audits and regulatory submissions. This template is essential for ensuring only vetted suppliers are used, reducing risks in your medical device supply chain.

Use this Bug Fixes Documentation List template to systematically record and track the evaluation, corrective actions, testing, and resolution of software bugs in regulated medical device software. Completing this template is essential whenever a software bug is identified and fixed, ensuring compliance with IEC 62304 requirements and supporting robust change management and traceability for audits and regulatory submissions.