TOPIC: Workshop: Practical Tools to be Compliant with the New European MDR
TOPIC DESCRIPTION:
The availability of the text for the new European Medical Device Regulation allows manufacturers to start the process of assessing the impact it will have on their activities, and what they will need to do to be compliant with the revised requirements. The MDR represents the largest change to the regulations for medical device in Europe since the original MDD/AIMD were put in place in the early 90s and will overhaul some of the basic principles under which manufacturers have been working under the current MDD.
Implementing the MDR requires a structured approach, since the transition to new MDR CE certificates can last several years and the transition time available is limited.
This training will provide you with the tools necessary to put together such a structured plan in order to make this complex transition as smooth as possible.
What are the top 3-7 takeaways / lessons that will be learned by attending?
- How to develop a structured EU MDR implementation plan
- Role and function of a coordinating core-team
- Phasing and prioritization to implement for success
- Some pitfalls and lessons learned from early adopter
Agenda
- Introduction new MDR
- Structure, scope, intentions
- Key changes (high level perspective)
- Transition from MDD to MDR
- Pre-Market: classification, conformity assessment, General Safety & Performance Requirements, labelling (including UDI), technical Documentation, impact on documented QMS
- Pre-Market continued
- Upstream: Supply chain & Manufacturing
- Downstream: Importer/distributor & EU Representative – PMS
- Clinical evaluation
- Exercise:
- Transition plan MDD compliance to MDR compliance
- Starting to implement
- MDR - ISO 13485:2016
- MDR – MDSAP
- Implementation program
SPEAKER: Dr. Keith Morel
SPEAKER BIOGRAPHY: Dr. Keith Morel is VP of Regulatory Compliance at Qserve Group, the largest EU based medical device consulting company. He heads up the Redwood City office, which along with the Boston, Amsterdam (HQ) and Nanjing make up Qserve’s main office locations.
He has worked in the medical device industry since 2000. Prior to joining Qserve, he was Senior Director or Regulatory Compliance at Accuray (a radiation oncology medical device manufacturer) where he was responsible for Internal and External audit processes & execution, Management Review, QMS design & governance and the internal Training process. He was also a Senior Project Manager for DEKRA Certification Inc. for 9 years. During his time at DEKRA he was lead auditor for CE (MDD) & ISO 13485:2003 and performed more than 100 audits & more than 200 Design Dossier/Technical File reviews. He was also DEKRA’s senior cardiovascular product expert, as well as a drug-device combination product expert and he holds an ASQ Certified Biomedical Auditor and a CMDCAS auditor certification.
Dr. Morel has also worked in R&D in the Medical Device industry in various roles as Engineer, Manager and Director, for several technologies including IVUS catheters and super-oxidized water products. He has both a Ph. D. in Plasma Physics (Nuclear Fusion) and a First Class Honours degree in Physics from Imperial College of Science, Technology and Medicine, in the UK.
WHO:
- QA/RA Roles
- Executives
- Engineering Roles
- Manufacturing / Operations
This meeting includes:
- Coffee and tea, breakfast and lunch
Attendance at this meeting may be applied as 6 points towards RAC re-certification