Effective Hazard Analysis to Meet FDA and ISO 13485: 2003 Risk Management Requirements 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. Live
Tuesday,
June 18, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
IEC62304 - Development and Maintenance of Critical Software Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Questions like: how much detail is required in the requirement specification? What is a software unit? How can integration testing be performed without test harnesses? will be answered. Practical guidance on how to employ a streamlined but yet compliant development process will be given. Live
Tuesday,
July 16, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
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