(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.
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.
Prior to BSI, he held significant positions at Impulse Dynamics, Sulzer Intermedics, Medtronic, and Medicomp, where his main work was in research and development with active implantable medical devices, including cardiac pacers, defibrillators, and devices for the treatment of heart failure. Routh holds a doctorate degree in biomedical engineering from the University of Miami, a masters degree in medical electronics and physics from the University of London (UK), and a bachelors degree in chemistry from the University of Sussex (UK). He is named as the inventor or co-inventor on 19 U.S. patents.
After the webinar, participants should be able to:
Founded in 1901 as the Engineering Standards Committee, BSI Group is a leading global independent business services organization providing standard-based solutions in more than 140 countries. BSI develops private, national, and international standards, certifies management systems and products, provides testing and certification of products and services, provides training and information on standards and international trade, and provides performance management and supply chain management software solutions.
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