(BSI: Reston, VA ) -- The first step in the risk management process is risk analysis. Risk analysis for medical devices requires the definition of a device's intended use, characteristics related to safety, identification of known and foreseeable hazards, and risk estimation for each hazard. Risk analysis techniques include preliminary hazard analysis (PHA), fault tree analysis (FTA), failure mode and effects analysis (FMEA), hazard and operability study (HAZOP), and hazard analysis and critical control point (HACCP).

Risk analysis is an evolutionary process with sequential refinement as the design details are elaborated and further data acquired. Join BSI for this informative presentation that will assist you in improving the effectiveness of your risk analysis process.

Speaker

Andre G. Routh, Ph.D., is the senior product expert of BSI Healthcare. He has more than 20 years of experience in research, development, and quality management in the medical device industry. At BSI, his primarily focus is CE marking for active implantable medical devices, and in addition, he is a qualified ISO 13485 lead auditor.

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