FDA-GMPs, known as Quality System Regulations (QSRs), and ISO 13485 require Risk Management as integral part of the development life cycle. The starting point for each risk management lifecycle is the Hazard and Risk Analysis which provides safety critical design input for the device design.
Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management Requirements - Webinar By GlobalCompliancePanel
25 April 2012, Wilmington, United States
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OnlineTraining, 1000 N West Street,, Delaware, Suite 1200, Wilmington, 19801, United States
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