Guideline for Design & Development for Medical Devices as per ISO13485
July 30, 2020
10:00 AM PDT | 01:00 PM EDT
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Product Id : 503223
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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:
Who Will Benefit:
- Design and development requirements
- Design and development output
- Design and development verification
- Design and development validation
- Design Changes
- Quality Engineers
- Quality Managers
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.