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SOP Design Control

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.
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SOP Design Control

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1. Purpose

The purpose of this SOP is to define the process for the design and development of hardware and system medical devices, ensuring compliance with applicable regulatory requirements and ensuring that the devices are safe and effective for their intended use. This process is established to control and verify product and manufacturing process design meet customer requirements and design specifications.

2. Scope

This SOP applies to all design and development activities related to hardware and system medical devices within quis nostrud exercitation. It covers initial concept development through to design transfer and post-market activities. This procedure does not apply to projects in the Research Phase, which includes early feasibility assessment and activities done pre-approval by business to be a commercial project. Medical device software (SaMD, SiMD) development is handled through SOP Software Development and is out of scope of this SOP.

3. Definitions

  • Design Control: A systematic approach to the design and development of medical devices.
  • Voice of Customer: The "Voice of the Customer" (VoC) refers to the feedback and insights gathered from customers about their preferences, expectations, and experiences with a product or service. It encompasses their needs, desires, and any issues they encounter.
  • User Needs: User needs refer to the requirements, desires, and expectations that users have for a product or service.
  • Design Input: Requirements that the device must meet.
  • Design Output: Design outputs are the tangible results of the design and development process that provide evidence that design inputs have been met.
  • Design Review: A formal documented evaluation of the design at various stages. This includes a systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
  • Design Transfer: Design transfer is the process of moving a product from the design and development phase into manufacturing and production. This step ensures that the device is produced consistently and in accordance with the specifications established during the design phase.
  • Design Verification: Confirmation that design outputs meet design inputs. This answers the question "Did we build it right? (Meeting design specifications)"
  • Design Validation: Confirmation that the device meets user needs and intended uses. This answers the question "Did we build the right thing?"
  • Design History File (DHF): A comprehensive collection of documents and records that provides evidence of the design and development process for a medical device or product. The DHF is required by some regulatory bodies, such as the FDA, to demonstrate compliance with design control requirements.
  • Device Master Record (DMR): A comprehensive document that contains all the information and specifications necessary to produce a medical device. It serves as a central repository for all documents related to the device's design, manufacturing, and quality assurance.
  • Device History Record (DHR): The DHR is a compilation of records that provides evidence that a specific medical device was manufactured according to its approved design and production specifications. It includes production records, quality control records, packaging and assembly records, and traceability data.
  • Bill of Materials (BOM): A comprehensive list that details all the components, parts, materials, and assemblies required to manufacture a medical device including part number, description, quantity, unit of measure, cost, assembly information, and supplier information.

4. Responsibilities

  • Software and Product Team: Conducts design activities, documentation, and reviews. Includes R&D, Systems Engineering, Development teams.
  • Quality Team (QA): Oversees the design control process and ensures compliance. Reviews and approves documentation related to design control.
  • Regulatory Affairs (RA): Ensures compliance with applicable regulations.
  • Business: Includes marketing team. Responsible for determining VoC and giving inputs to design team for User Needs.

5. Procedure

5.1 Phase 1: Planning and Input

5.1.1 Develop a Design Plan:

  • Identify project scope, objectives, milestones, and resources required, as needed.
  • Define roles and responsibilities of team members.
  • Establish a timeline for design activities if needed.

5.1.2 Gather Requirements:

  • Collect user needs, regulatory requirements, and standards applicable to the device.
  • Document all design inputs in design input documentation.

This phase marks the initiation of product development activities with an emphasis on design input development and project planning, including:

  • User Needs, Intended Use, Use Specifications
  • System/Hardware Requirement Specifications
  • Supplier management and quality planning
  • Regulatory strategy
  • Clinical evaluation plan
  • Design transfer strategy
  • Risk management plan
  • Preliminary hazard assessment
  • Cybersecurity plan, as needed
  • Usability plan

5.1.3 Review and Approval:

  • Review documentation from design inputs to ensure all requirements are captured. Document findings, decisions, and actions taken, as needed.
  • Maintain records of the reviews
  • Obtain approval from QA, RA, Business, and Product teams as relevant.

5.2 Phase 2: Design and Development

5.2.1 Develop Design Outputs:

  • Create detailed specifications, drawings, and other documentation, as needed.
  • Ensure that all outputs are traceable to the design inputs.

5.2.2 Design Transfer Plan:

  • DMR and BOM
  • Production-equivalent released drawings and specifications, including packaging and labeling
  • Manufacturing process
  • Test method validation

5.2.3 Risk Analysis:

  • Bottom up risk analysis, as needed: dFMEA, pFMEA, uFMEA, FTA
  • Top down: Risk Assessment
  • Verification plan and protocols (including any planned usability verification and validation activities)
  • Hardware design documents and/or characterization reports
  • Completed supplier qualification activities

5.2.4 Review and Approval:

  • Review design output to confirm alignment with design inputs. Document findings, decisions, and actions taken, as needed.
  • Obtain approval from the QA, RA, Business and Product teams as relevant.

5.3 Phase 3: Verification and Validation

5.3.1 Verification:

  • Conduct verification activities to ensure design outputs meet design inputs.
  • Document verification results in the Verification Report.

5.3.2 Validation:

  • Perform validation activities to confirm the device meets user needs.
  • Document validation results in the Validation Report.

5.3.3 Deliverables:

This phase verifies the device design and confirms that the design outputs meet the design inputs. Results from the design verification phase provide objective evidence that the device design and related manufacturing processes meet all specifications. The following documentation are created/updated:

  • Risk Assessment
  • Risk management report
  • Traceability Matrix
  • Verification and Validation Reports
  • Production Equivalence Reports, if needed
  • Usability Reports
  • Change Management (if any) - Any design changes of released medical products during this phase shall be documented including required verification and validation activities or the rationale for not doing so.
  • Clinical Evaluation Plan
  • Technical Reports: These serve to provide prepared responses to key technical guidance (ie: FDA's on EMC, wireless technologies) and/or regulations, outlining the associated design, labeling, test considerations, and references to supporting verification reports.

5.4 Phase 4: Design Transfer and Market Release

5.4.1 Prepare for Design Transfer:

  • Train manufacturing personnel on the design and manufacturing processes, if needed.

Design transfer is the transfer of the product design output to production specifications, procedures, and personnel. This includes assurance that (a) the specifications essential for the proper functioning of the device have been identified, and (b) the element of the design being transferred satisfies the requirements of the Product Specification (i.e., design input), as appropriate. The design transfer strategy will be defined in the planning phase and implemented. For devices produced by contract manufacturers, design transfer involves the review of contractor DMR documents and associated quality system records, as needed. Process validation involves the determination of which processes require validation, development of an appropriate rationale for processes not validated, and the completion of process validation studies for the processes that require validation. These activities are documented in the Master Process Validation Plan. The process validation will be documented. Process Validation (upon successful completion) will qualify the manufacturing facility for commercial production of the device. Documentation of Process Validation performed at contract manufacturer will be referenced as needed on the Manufacturing transfer checklist.

5.4.2 Conduct Design Transfer Activities:

  • Transition the design to manufacturing, ensuring adherence to specifications.
  • Design transfer is complete and documented.

5.4.3 Conduct Market Release Activities:

This phase involves readying marketing materials, training (internal and/or external), post-market processes, inventory and distribution centers, and once regulatory approval is received in the applicable region(s). After regulatory approval, the product listing(s) is entered into Global Unique Device Identification Database (GUDID) with its Global Trade Identification Number (GTIN) and other information specific to the product. GS1 can be used to generate a new GTIN for the product. It is then published and becomes publicly viewable on the GUDID database.

  • Regulatory Strategy updated, as needed
  • Clinical evaluation report, as needed
  • Post-market surveillance plan, as needed
  • Post-market clinical follow-up plan, as needed
  • Summary of Safety and Clinical Performance, as needed
  • UDI-DI and UDI-PI assignment and registration within the EUDAMED database and competent authorities, as needed

5.4.4 Review and Approval:

  • Conduct a design transfer and market release review to confirm readiness. Document findings, decisions, and actions taken, as needed.
  • Maintain records of all review.
  • Obtain approval from the QA, RA, Business, and Product teams as well as Person Responsible for Regulatory Compliance (PRRC), as needed
  • All market release activities completed.

5.5 Phase 5: Post-Market Activities

5.5.1 Monitor Device Performance:

  • Collect and analyze post-market data for device safety and effectiveness.
  • Implement corrective and preventive actions as necessary.
  • Conduct post-market clinical follow-up activities as defined in the post-market clinical follow-up plan.

5.5.2 Update Design Controls:

  • Review and update design documentation based on post-market feedback.
  • Update Risk Assessment as needed.

6. Training

All personnel involved in the design and development of medical devices must undergo training on this SOP and the principles of design controls.

7. References

  • FDA Quality System Regulation (21 CFR Part 820)
  • ISO 13485:2016
  • Regulation (EU) 2017/745 on medical devices (MDR)
  • SOP Software Development
  • SOP Usability Engineering
  • SOP Risk Management
  • SOP Document Record and Control

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