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Effective Hazard Analysis to meet FDA and ISO13485:2003 Risk Management Requirements

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$295.00
  • Refund Policy


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. Based on many years of experience and tens of hazard analyses the presenter will give practical guidance and helpful insights on how to efficiently perform a comprehensive hazard analysis and avoid commonly made mistakes. This will allow your company to streamline the analysis process and generate a compliant and meaningful document that will allow providing valuable design input and meeting regulatory requirements.

Why should you attend: Performing requires Hazard and Risk Analysis often poses a challenge for development teams. How detailed does the analysis have to be? What is the difference between hazard and harm, hazard and hazard cause, Hazard analysis and FMEA, etc.? How do we combine the risk rating when different mitigation measured are used simultaneously? This presentation will try to answer all these questions and provide a partial guidance on how to effectively perform a Hazard and Risk Analysis.

Areas Covered in the Session:
  • Structure of a Risk and Hazard Analysis document
  • Stakeholders and participants
  • How to conduct a hazard analysis meeting
  • Meeting ground rules
  • Hazard and Harm characteristics
  • Methods to identify potential hazards
  • Risk and Risk Rating methods
  • Risk mitigation strategies
  • Risk assessment and Residual Risk
Who Will Benefit:
  • Project Leaders
  • Design Engineers
  • Regulatory
  • Quality
Speaker Profile
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

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