FMEA and Risk Management for Medical Devices

This FMEA webinar will discuss how to use FMEA as a tool for risk assessment and how to make it an integral part of risk management. What are the harmonized standard of risk assessment of medical devices under MDD and how to use it in design control risk management.

Why Should You Attend:

FMEA (Failure Mode Effects Analysis) has long been recognized as a valuable tool in risk assessment and should be considered as an integral part of risk management. FMEA has been used as part of Risk Analysis under the obsolete standard EN 1441 - Risk Analysis for Medical Devices. The term “Risk Analysis” is no longer appropriate for medical device manufacturers and has been replaced by “Risk Management”. EN 1441 is now a withdrawn standard and ISO 14971:2007 Medical Devices -- Application of Risk Management to Medical Devices has been the harmonized standard for risk assessment of medical devices under the medical devices directives and has been emphasized in the new ISO 13485:2016.

This presentation will acquaint one with the various terms used in risk management and the importance of ISO 14971 & ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.