Translating government gobbledygook into English is no small task. And the FDA isn’t the only regulator to worry about. Misinterpret a few words of the EU regs and see how much trouble you’ll land in.
Lucky for you we have done the work for you.
Biological Risk Evaluation and Management for Medical Devices shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical.
The webinar also includes several reference materials related to risk management and biocompatibility evaluation aids including:
*A table comparing the requirements of ISO standard 14971, ISO standard 10993 and ISO technical report 15499;
*A table comparing the risk management requirements contained in the former EU Medical Device Directives with those in the new MDR; and
Biological Risk Evaluation and Management for Medical Devices will give you an understanding of how to evaluate biological hazards associated with a device within a risk management framework.
Who Will Benefit:
*Design Project Leaders
*Risk Management Professionals