FMEA and risk management for medical devices
Overview: FMEA (failure mode effects analysis) has long been recognised 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 The term "risk analysis" is no longer appropriate for medical device manufacturers and has been replaced by "risk management". EN 1441 is now a withdrawn standard and ISO 14971:2007 medical devices - application of risk management to medical devices has been the harmonised standard for risk assessment of medical devices under the medical devices directives and referred to in ISO 13485:2003. This presentation will acquaint one with the various terms used in risk management and the importance of ISO 14971 and ISO 13485 in the managements of risks during the life cycle of medical devices starting with design and manufacture.
Areas covered in the session:
FMEA and FMECA
Risk management vs.ISO 13485:2003
Risk management and ISO 14971
FDA's risk management requirements
Design control risk management
Medical device directives and risk management
Who will benefit: companies interested in understanding and implementing a quality management system that is universally accepted by regulatory authorities. Employees who will benefit include:
Quality and regulatory professionals
Quality system auditors
Manufacturing and design engineers
Marketing product managers
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.
Date: 20 September 2012Time: 10:00 - 11:00
Venue: Online Training, Wilmington
Cost: $245.00
More info:
Online Training