Risk Management - Implementing ISO14971: 2019
  • CODE : YUVA-0005
  • Duration : 60 Minutes
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Yuval Shapiro is the founder of QWV – Quality with Value, QA/RA Services. An expert for products and companies primarily related to medical devices that meet the real needs of their clientele. Substantial experience gained in various multi-discipline technology industries (Military, Telecom & Medical Devices), and give a high value contribution to quality and reliability projects related to the medical device and telecom industries.

More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH&S Systems; QA/RA representative in R&D Projects; Risk Analysis as per ISO14791& ISO31000‎; EMC & Safety Certifications.

Mr. Shapiro shall present the basic principles and practices of the Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management. Present some common errors when dealing with risk management. Present the new additions and changes to the new standard.

Risk approach has become a mandatory practice during the Product Realization of Medical Devices. This practice should be applied as per ISO14971: 2019, the brand-new revision of the well-known and practice standard.

Areas Covered    

  • Risk-based approach
  • Risk Management fundamentals
  • Risk Analysis
  • FMEA
  • ISO14791: 2019

Course Level - Intermediate

Who Should Attend   

  • Quality Assurance  Managers
  • Quality Assurance Engineers
  • R&D Managers, R&D Engineers
  • Production Managers and Production Engineers

Why Should You Attend

Refresh your knowledge with Risk Management basics and practices and become aware of the new requirements presented by ISO14971: 2019.

  • $200.00

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