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Medical Device Complaints, MDR’s and Recalls

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Date: 14-May-13 to 14-May-13
Location: Online Event / California / United States
Category: Healthcare & Pharmaceuticals Conferences & Trade Fairs

This webinar on medical device complaint handling will discuss in detail the FDA regulations and the regulatory process with respect to medical device complaint handling, reporting and recalls.

Visitors

Quality & Regulatory Professionals,Manufacturing & Design Engineers,Marketing Product Managers

Exhibitors

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.

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