Risk Management - Implementing ISO14971: 2019
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.
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 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.
- Risk-based approach
- Risk Management fundamentals
- Risk Analysis
- 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 Attend
Refresh your knowledge with Risk Management basics and practices and become aware of the new requirements presented by ISO14971: 2019.