IVDR 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.


IVDR training day from Andreas Stange & Marta Carnielli, 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 IVDR, 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 10th March.

Course Outline

Proposed agenda:

• Introduction to IVDR legislation
• Major changes compared to IVD
• Classification in IVDR, emphasis on new risk classes A, B, C and D. Examples of classification, including software.
• Regulatory person.
• Requirements for economical operators.
• Requirements on performance evaluation.
• Requirements on PMS, Vigilance.
• Latest on revised timelines and Eudamed.
• Upcoming MDCG documents.
• Tips from TUV on implementing IVDR and common pitfalls.
• Update on Notified Body designation status and capacity considerations

Instructors: Andreas Stange & Marta Carnielli

Dr. Andreas F. Stange is a vice president for the Medical and Health Services group at TÜV SÜD Product Service. He serves as the global responsible for the In-vitro Diagnostic Devices business line. Besides that, he is also overseeing TÜV SÜD`s Medical Health Services in North-East Asia.

Pharm D Marta Carnielli is IVD Technical Officer at TÜV SÜD. She is responsible for regulatory information, represent TÜV SÜD in relevant IVD regulatory committees and conferences and support management and technical experts with the interpretation of regulatory requirements.

Online

The course is held online 3rd of April 2020. The course starts at 08.30 and finishes 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 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: R14080 when register 3 or more.

Other information

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