The New EU-Medical Devices Regulation (745/2017)
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.
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.
On May 2017 the European Union has released its new regulation concerning Medical Devices.
This regulation introduces many challenges to the Medical Devices industry.
- Principle points
- The Scope of the Regulation
- General Safety & Performance
- Changes on Notified Bodies
- Classification of Devices
- Post Marketing Surveillance
- Quality Management Systems
- Useful Information
- Certification Expiration
- CE Marking
Course Level - Basic-Intermediate
Who Should Attend
- QA/RA engineers
- QA/RA managers
- Medical Devices Engineers
Why Should 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?