EU Medical Devices Regulation: The Practice
  • CODE : YUVA-0023
  • Duration : 90 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.

The EU Medical Device Regulation (MDR 745/2017) represents a considerable change from the directives it is replacing. Device manufacturers who conduct business in the EU must start their transition now in order to meet the deadline. This training is the first peek into this uncharted realm.

During this class, participants will be introduced to the new requirements in the Medical Device Regulation (MDR), including those related to quality systems, product classification rules, technical documentation, clinical evaluations, Unique Device Identification (UDI), and postmarket surveillance. Also, learn how to plan an efficient transition.

Areas Covered

  • Principle points
  • The Scope of the regulation
  • General safety and performance
  • Changes on notified bodies
  • Classification of devices
  • Post marketing surveillance
  • Quality management systems
  • Confidentiality
  • Useful information
  • Certification expiration
  • CE marking

Course Level - Intermediate

Who Should Attend

QA/RA engineers, QA/RA managers, Medical Devices Engineers

Why Should You Attend

One should attend, in order to start understanding what is the new challenge and ways to handle it. How to establish the correct strategy? What is newly adopted as a requirement, and what did not receive a proper answer, yet?

Topic Background

On May 2017 the European Union released its new regulation concerning Medical Devices. This regulation introduces many challenges for the Medical Devices industry.

  • $200.00

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