Biological Evaluation of Medical Devices
New for 2019
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 will be the easiest way to meet the relevant essential product safety requirements of the Medical Device Regulation. Understanding a risk management approach to biological evaluation 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 for interactive discussion with experts in this field.
Who should attend?
This seminar will be of importance to those in the medical device industry from the following departments:
- Regulatory affairs
- Product safety/toxicology
- Analytical chemistry
- Risk assessment and risk management
- Materials research and evaluation
- It will be of particular interest to Regulatory Authorities, Notified Bodies and CROs regulating or supporting the medical device industry