MDR training day from Bassil Akra, TÜV SÜD. An opportunity to learn of requirements, challenges and useful insights directly from one of Europe’s largest and leading notified body for Medical Devices.
Who should attend?
QA/RA staff, R&D staff, Management, Sales, Marketing, Investors.
Learning objectives
Acquiring an overview of MDR requirements and the latest news and interpretations as well as insights to develop appropriate strategies.
Course Outline
Proposed agenda:
- Introduction to MDR legislation
- Classification in MDR, emphasis on new and revised rules such as 11 (MDCG 2019-11)
- Regulatory person
- Requirements for economical operators
- Requirements on ´clinical evaluation
- Requirements on PMS, Vigilance
- Latest on revised timelines and Eudamed
- Upcoming MDCG documents
- Tips from TUV on implementing MDR and common pitfalls
Instructor: Dr Bassil Akra
Dr. Bassil Akra is the vice president of global strategic business development in medical health service of TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. He is involved in the development of several European guidance documents and standards. He is member of the European Clinical Investigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other Guidance Documents on Innovative Devices. Dr. Akra is member of the German MDR Implementation Working Group, the NAKI. He is also member of the new MDR European task forces such as the one on PSUR, SSCP, Clinical Equivalence and sufficient clinical data.
Time and venue
The course is held 23rd of April 2020 at Apotekarsocieteten, Wallingatan 26A in Stockholm. Registration and breakfast starting at 08.30. The course starts at 09.00 and finishes approximately at 16.30.
Participation fee and registration
The registration fee is 6.900 SEK until March 21st and thereafter 8.500 SEK. The fee includes digital documentation, certificate in digital format, lunch and coffee/refreshments. Printed documentation can be obtained for an extra cost of 500 SEK. All prices exclude VAT.
Other information
For information such as cancellation policy, participant list, GDPR – see “Registration Terms” to the right.
Inlägget MDR training with TUV SUD dök först upp på Läkemedelsakademin.