A Gap Assessment for EU MDR 2017 and ISO 10993 is a systematic process to identify discrepancies between a medical device's current compliance status and the requirements of these regulations and standards. It helps manufacturers ensure their devices meet regulatory and safety standards before market placement.
A Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) are essential for assessing the biological safety of medical devices under ISO 10993-1. The BEP outlines the evaluation strategy, while the BER summarizes results, ensuring the device is safe for its intended use.
A Toxicology Risk Assessment (TRA) per ISO 10993-17 is a process to evaluate health risks from leachable substances in medical devices, establishing safe exposure limits to ensure patient safety.
A Risk Management Plan (RMP) per ISO 14971 is a documented framework for identifying, evaluating, controlling, and monitoring risks of a medical device throughout its lifecycle, ensuring risks are minimized and patient safety is prioritized.
Designing biocompatibility studies per ISO 10993 and ISO 18562 involves planning and conducting tests to evaluate the biological safety of medical devices, ensuring they pose no risks to patients during body or breathing gas pathway contact.
Material Qualification and Biocompatibility are critical processes in ensuring the safety and performance of medical devices.
Study Placement, Monitoring, Report Preparation/Review are essential steps in conducting biocompatibility or other testing for medical devices:
Medical devices play a vital role in healthcare, but ensuring their safety goes beyond performance—it’s about understanding their potential impact on patients at a chemical level. ISO 10993-17 provides a comprehensive framework for the toxicological risk assessment ofconstituents that may leach from medical devices.
What is ISO 10993-17?
It’s a critical part of the ISO 10993 series, focusing specifically on evaluating the potential health risks posed by leachable substances from medical devices. These substances may include residual chemicals, degradation products, or process-related impurities.