Design And Development for Medical Devices
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.
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?
Medical Device companies are required to establish and maintain a structured design and development process to ensure a reliable, effective, and reproducible product in a repeatable process.
- Design and development requirements
- Design and development output
- Design and development verification
- Design and development validation
- Design Changes
Course Level - Intermediate
Who Should Attend
- Quality Engineers and Quality Managers
Why Should You Attend
In this webinar, you will learn the basics of design and development requirements as per the standards of the medical device (ISO13485), the expected process, and the desired documentation as per those requirements.