Biological Evaluation of Medical Devices
The Biological Evaluation of Medical Devices Training Course provides a comprehensive overview of assessing the biocompatibility and safety of medical devices. It covers ISO 10993 standards, test methods, and risk management strategies to ensure devices are safe for human use. Participants will learn to evaluate materials, conduct biological risk assessments, and ensure compliance with global regulatory requirements, making this course essential for professionals involved in medical device devel
The ISO 10993 series of standards covering biological evaluation of medical devices is well established and regulatory authorities worldwide expect compliance. In Europe, compliance with the standards is the easiest way to meet the essential product safety requirements of the MDR and understanding a risk management approach to biological safety is essential.
This seminar will provide key guidance on how to use the standards and successfully apply a risk management approach to the biological evaluation of medical devices. There will be plenty of time during the programme for interactive discussion with experts in this field.
Benefits of attending:
- Understand biological risk management
- Clarify the requirements of ISO 10993-1
- Learn what endpoints need to be addressed in a biological risk assessment
- Establish how much chemical characterisation is necessary
- Hear the FDA’s approach to ISO 10993
- Better understand Medical Device Directive (MDD) safety requirements vs the Medical Device Regulation (MDR) safety requirements
- Know how extractables and leachables impact on medical device safety
- Discuss the Japanese and Chineserequirements
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.