Medical Devices – Developing Effective Post Market Surveillance and Complaint Handling Systems
Course - Philadelphia, PA, United States
As users and regulatory agencies are becoming less ‘tolerant’ of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post market surveillance and outline how to apply the requirements to medical devices. Topics include: complaint handling & vigilance systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies, compliance requirements & meeting them, and complaint systems inspections.
Throughout the course, examples and case studies will help participants apply the concepts being covered.
(Photo courtesy of http://www.cfpie.com/)
19th - 20th July 2012
Doubletree Hotel by Hilton, Philadelphia/Valley Forge
301 West Dekalb Pike, King of Prussia, PA 19406, United States
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