Guideline for Design & Development for Medical Devices as per ISO13485

Yuval Shapiro
Yuval Shapiro
Thursday, July 30, 2020
10:00 AM PDT | 01:00 PM EDT
60 Minutes

More Trainings by this Expert   Product Id : 503223

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
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Mr. Yuval Shapiro shall present the requirements for design and development as per medical devices standards (ISO13485), and some common practices.

What is the V-model? How is it applied in Medical Devices? What is the required documentation for the design and development of medical devices?

What is verification in contrast to validation? Could those be combined? How changes should be managed?

Why should you Attend: In this webinar you will learn the basics of design and development requirements as per the medical devices standards (ISO13485), the expected process and the desired documentation as per those requirements.

Areas Covered in the Session:

  • Design and development requirements
  • Design and development output
  • Design and development verification
  • Design and development validation
  • Design Changes

Who Will Benefit:
  • Quality Engineers
  • Quality Managers

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.

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