MDR training with TUV SUD – Online

Covid-19: Due to development of corona-covid 19 this training day will be held as an interactive Online Training.

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 notified bodies for Medical Devices.

Who should attend?

QA/RA staff, R&D staff, Management, Sales, Marketing, Investors.

Learning objectives & Opportunity to ask questions

Get the latest news and interpretations regarding MDR, as well as useful insights from a Notified Body to develop appropriate strategies.

All participants have the opportunity to submit questions in advance for the lecturers. Submit your question/s to jenny.hagberg@lakemedelsakademin.se, preferably by 30th March and latest by 18th April

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 for Technical Documentation
• General Safety and Performance Requirements
• Requirements on clinical evaluation
• Requirements on PMS, Vigilance
• Latest on revised timelines and Eudamed
• 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.

Online

The course is held online 23rd of April 2020. The course starts at 08.30 and finishes approximately at 17.15. The link for the online-course will be sent to all participants approximately 2 days before the course starts.

Questions and Topics to discuss

All participants have the opportunity to submit questions in advance for the lecturers. Submit your question/s preferably before March 23rd to jenny.hagberg@lakemedelsakademin.se and latest by 5 days prior training.

Participation fee and registration

The registration fee is 6.900 SEK excl. VAT. The fee includes digital documentation, certificate in digital format. Discount code: D14079 when register 3 or more.

Other information

For information such as cancellation policy, participant list, GDPR – see “Registration Terms” to the right.