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MDR/IVDR is here to stay – Facts and Consequences

Dato og tid

Torsdag d. 1. juni 2017 kl. 13:00 til 17:00

Tilmeldingsfrist

Torsdag d. 18. maj 2017 kl. 23:00

Sted

Medicologic A/S - Auditorium, Arne Jacobsens Allé 17, 2300 København Medicologic A/S - Auditorium
Arne Jacobsens Allé 17
2300 København

MDR/IVDR is here to stay – Facts and Consequences

Arrangementsbeskrivelse



The final texts of the Medical Device Regulation/In Vitro Diagnostic Regulation, which will replace the current Medical Device Directive (93/42/EEC), Active Implantable Medical Device Directive (90/385/EEC), and In Vitro Diagnostic Directive (98/79/EEC) is now published.

These long awaited texts brings with it more scrutiny of technical documentation; the requirement for re-classification of more than 75% of IVDs; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices throughout the supply chain.

This will put a heavy burden upon medical device manufacturers with the requirement for more and higher documentation level having an impact on costs and not least time-to-market.

On this seminar we would like to take you through the new requirements and show you what these actually mean. In other words we would like to be your preferred partner in preparing for your readiness for the new MDR/IVDR so you can start acting within your organization.

Program

13.00
Check-in and welcome
Michael Funder, CEO - Medicologic

13.15
The new Medical Device Regulation
Randi Hauerberg, Partner, Regulatory Affairs & Quality Management - Medicologic
Transition from MDD into MDR – what are the timeline, changes and consequences?

14.20
MDR software requirements
Mie Østergaard Jørgensen, Ph.D., Principal Consultant - DELTA
Software has long been a part of the legislation for medical devices, but with the new regulations focus is increased and the requirements more stringent. We take you through the software specific changes and give you an idea of ​​the impact they will have for developers of medical software.

14.45
Break

15.00
The new In Vitro Diagnostic Regulation 
Gert Nielsen, Senior Regulatory Affairs Consultant - Medicologic
Transition from IVDD into IVDR – what are the timeline, changes and consequences?

16.05
Usability testing: What if you could see your device through the eyes of the users?
Jesper Ejdorf Brøsted, Ph.D., Human factors specialist - Force Technology
Data-driven design inputs, improved user experience, safety measures, and competitive advantage.

16.30
Networking including sandwich and drinks

We look forward to sharing the latest knowledge with you.

A certificate can be issued on request.

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