Risk Management - Implementing ISO14971: 2019

IMG
Instructor
Yuval Shapiro
Duration: 60 Minutes
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Overview:

Mr. Shapiro shall present the basic principles and practices of 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 of the new standard.

Why you should Attend:

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

Areas Covered in the Session:

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

Who Will Benefit:

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

Speaker Profile

Yuval Shapiro is the founder of QWV - Quality with Value, QA or 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 and D RA and QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). More than 20 years of experience in QA; including MD&D RA & QA; QMS (21CFR - Part820, ISO13485, TL9000, CMDCAS, ISO9001). EH and S Systems; QA or RA representative in R and D Projects. Risk Analysis as per ISO14791 & ISO31000. EMC & Safety Certifications.