Overview
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.
In May 2017 the European Union has released its new regulation
concerning Medical Devices. This regulation introduces many challenges
to the Medical Devices industry.
Why should you Attend
One should attend, in order to start understanding what the new
challenge and ways are to handle it. How to establish the correct
strategy? What is newly adopted as a requirement, and what?
Areas Covered in the Session
- Principle points
- The Scope of the Regulation
- General Safety & Performance
- EUDAMED
- Changes on Notified Bodies
- Classification of Devices
- Post Marketing Surveillance
- Quality Management Systems
- Confidentiality
- Useful Information
- Certification Expiration
- CE Marking
Who Will Benefit
- QA/RA Engineers
- QA/RA Managers
- Medical Devices Engineers
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.
Instructor
Yuval Shapiro
