A quality management process that rectifies identified issues and/or implements measures to prevent future problems.
It involves taking steps to fix existing non-conformities and proactively addressing potential risks before they materialize. This process ensures products meet strict safety and quality standards.
A set of regulations that govern the safety and performance of in vitro diagnostic devices within the EU. This applies to devices concerning the examination of specimens such as blood and tissue to understand predisposition, treatment, response or other information in relation to a medical condition or disease.
A set of legal requirements to ensure the safety and performance of medical devices that come into direct contact with humans, sold within the EU. This applies to products from bandages to implantable devices.
A report that summarizes the results and conclusions of the analysis of the post-market surveillance data gathered as a result of the Post-Market Surveillance Plan. The comprehensive report that presents an evaluation of the risk-benefit balance of a product, considering all available information since the product was marketed or since the last report.
It includes data on the product's safety, including side effects, incidents, any corrective actions taken, and any new indications or modifications in usage based on real-world evidence. The PSUR helps regulatory authorities continuously monitor products' safety and effectiveness. A PSUR is only required for Class IIA, IIB and III devices.
This process involves the continuous monitoring and collection of clinical data on a medical device after it has been approved for use. This data helps to confirm the safety and effectiveness of the device throughout its expected lifetime.
PMCF activities can include clinical trials, registry studies, and the review of relevant scientific literature.
A requirement for all Class I medical devices under the EU MDR framework. It provides a summary of post-market surveillance data, detailing the safety and performance of devices collected through post-market surveillance activities in your post-market surveillance plan.
An international standard that outlines the requirements for a quality management system specific to the medical device industry.
ISO 13485 focuses on ensuring product quality through risk management, company processes, regulatory compliance, and maintaining effective product processes for the safe design, manufacture, and distribution of medical devices.
It is applicable to organizations regardless of their size or type, except where explicitly stated, and provides a framework for implementing regulatory and quality management system requirements globally.
The process of monitoring the safety and effectiveness of a medical device after it has been released on the market to ensure that any potential issues are identified and addressed in a timely manner.
PMS activities can include the collection and analysis of data related to device performance, adverse events, patient feedback, and clinical outcomes.
A requirement for Class III and implantable medical devices. It provides a concise overview of a device's safety and clinical performance, including relevant clinical evaluation data.
The SSCP is intended to be accessible to the public, especially healthcare professionals, to aid in informed decision-making about using these higher-risk devices. It includes but not limited to information about the device's intended purpose, indications, contraindications, summary of clinical evaluation, and any residual risks associated with its use.
An order that mandates that manufacturers conduct further studies to assess the device's safety and effectiveness in a real-world setting. It is typically applied to higher-risk devices, such as those that are implanted or life-sustaining, to ensure ongoing public health protection and address specific concerns that arise after the device is in use. These orders can be issued anytime, rather than just during the approval process.
This exemption allows for the marketing of medical devices intended to treat or diagnose diseases affecting fewer than 8,000 individuals annually in the U.S. These devices may not have to demonstrate effectiveness but must prove safety and probable benefit.
Studies that the FDA may require after PMA approval to gather additional information about a product's safety, effectiveness, or optimal use, often to address specific questions about the post-market performance of advanced medical devices.
The FDA's process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, which are those that support or sustain human life or present a potentially high risk of illness or injury.
This combines the FDA's Quality System Regulation (QSR) regulations and ISO 13485. It refers to the set of standards and regulations that govern the quality management systems of medical device manufacturers.
These regulations outline the processes, procedures, and documentation required to ensure that medical devices are consistently designed, produced, and controlled to meet specified quality standards.
The aim is to ensure the safety and effectiveness of medical devices throughout their lifecycle, from design and manufacturing to distribution and post-market surveillance. In the U.S., the FDA enforces these requirements under 21 CFR Part 820, while internationally, ISO 13485 is widely recognized as the standard for medical device quality management systems.
Outlined in 21 CFR Part 820 and establishes the requirements for the quality management systems of manufacturers and suppliers of medical devices intended for the U.S. market.
The regulation encompasses the methods and documentation for the design, testing, production, control, quality assurance, labeling, packaging, storage, and shipping of medical devices. It requires manufacturers to implement a comprehensive quality system that covers all stages of a device's lifecycle, from initial conception to delivery and post-market surveillance.
The QSR is critical for compliance with FDA regulations and is foundational for maintaining high standards of quality and safety in medical device manufacturing. In 2024, it was combined with ISO 13485 and is now called the QMSR.