Over four days, TÜV SÜD will present a series of 14 different live webinars addressing the most challenging issues of the Medical Device Regulation (MDR), In-Vitro Diagnostic Regulation (IVDR) and testing and certification services. TÜV SÜD’s global network, comprising experienced medical doctors, engineers, chemists and biologists, offers significant added value on the international medtech market. From experience, we know that medtech questions related to testing, certification and approval are best clarified directly in face-to-face meetings with experts in the field. Like last year, participants on all four days will again have the possibility to discuss their specific needs and objectives in virtual one-to-one meetings.

Digital Dialogues Vol. 2 is another valuable event for all manufacturers, regulators and quality, product development and IT professionals in the health and medical-device industry who are seeking to drive innovation and lead the market.

On each of its four days, Digital Dialogues Vol.2 will offer several online webinars. To give participants maximum flexibility in their planning, the sessions will be held in the mornings from 8:30 am and repeated in the afternoons from 4:30 pm (CET). All webinars are held in English and are free of charge.

Programme details of the 4-day online event:

17 May: MDR
The first day of the webinar series is dedicated to the highly topical Medical Device Regulation (MDR), whose (extended) transition period is slated to end on 26 May 2021. The MDR continues to present manufacturers and Notified Bodies with a relatively extensive list of requirements. The TÜV SÜD specialists will provide detailed information about the specified requirements.

8:30 am and 4:30 pm Medical device software – Marco Caproni
09:30 am and 5:30 pm Cyber Security – Jan Küfner / Dr Abtin Rad
10:30 am and 6:30 pm Basic UDI-DI from the view of a Notified Body – Julia Hoyer
11:30 am and 7:30 pm Article 117 MDR – Notified Body opinion – Dr Christiana Hofmann

18 May: Testing (Part 1)
Days two and three of the webinar series will focus on the testing of medical devices. The programme covers topics such as GSPR, functional safety, electromagnetic compatibility, environmental simulation, chemical characterisation and MRI.

09:30 am and 5:30 pm MDR Annex I: General Safety and Performance Requirements (GSPR) – Compliance through evidence – Martin Witte
10:30 am and 6:30 pm Functional and single fault safety in medical devices – Alba Marina Malavé Dos Santos und Dr. Abtin Rad
11:30 am and 19:30 pm Medical device testing for radio compliance – Requirements of RED – Matthias Stumpe

19 May: Testing (Part 2)
09:30 am and 5:30 pm Environmental simulation and testing – Wolfgang Jakobi
10:30 am and 6:30 pm Chemical characterisation and the importance of a toxicological risk assessment – Dr Christoph D. Lindner
11:30 am and 7:30 pm MRI – safety of medical devices – Mahdi Abbasi

20 May: IVDR
The Regulation on In-Vitro Diagnostic Medical Devices (IVDR) is on the agenda on day four of the webinar series. Beyond the exchange of experience from first IVDR certification projects, experts will give an overview of the classification rules and the MDCG guidance document and take an in-depth look at possible solutions for fulfilling the requirements and at applicable tests.

8:30 am and 4:30 pm Update on IVDR implementation – Dr Andreas Stange
09:30 am and 5:30 pm IVD classification under the IVDR – Marta Carnielli
10:30 am and 6:30 pm Instruments / Software-specific requirements under IVDR – Dr Julien Senac

Further information and registration for the Digital Dialogues at:
https://www.tuvsud.com/en/events/digital-dialogues