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Recorded John Chapman Recalls & Vigilance-When to Report Complaints This webinar will acquaint one with the lessons learned from over 30 years of adverse events and complaints. Recorded View Anytime $295.00 John Chapman Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Recorded View Anytime $295.00 John Chapman Regulatory Complaint Handling, Vigilance & Recalls Improper complaint handling can result is serious regulatory problems as well as hitting the bottom line. Recorded View Anytime $295.00 John Chapman FMEA and Risk Management for Medical Devices This presentation will explain 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. Recorded View Anytime $295.00 John Chapman ISO 13485 as a Quality Management System for Medical Devices This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. Recorded View Anytime $295.00 << >>