Biological Evaluation of Medical Devices

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 Chinese requirements