Event: Make Medical Device Creation Easier

December 1st, 9-17 in Copenhagen

Medical device makers want to improve products' time to market while complying with an ever increasing regulatory complexity. When managed, rapidly changing regulations are opportunities to be used to build a competitive advantage. During this day we highlight current regulatory changes, how they impact medical device development practices, and how to turn these challenges into opportunities, especially when combined with new business concepts, new technology and manufacturing solutions.

Location: Carlsberg Business Center, Valby Langgade 1, 1799 Copenhagen V. Show on Google Maps

The event is free of charge!


Morning Session: Making Medical Device Creation Easier

08:30 - 09:00 Registration & Breakfast
09:00 - 09:15 Welcome, Petter Sahlin, TechniaTranscat
09:15 - 10:15 Turning regulatory complexity into a competitive advantage
The MDR and revised 13485 standard are just some current examples of fundamental changes with impact on our QMS and development processes. In this session we introduce the most important regulatory changes, business trends and how they impact the product launch, design controls and product maintenance processes. The session details the basic requirements on the product development backbone and PLM platform which have to be in place in order to meet these changes.
10:15 -11:00 UDI – from challenging deadline to increased change throughput, Tommy Røsholt, Oticon
Through a use case with the UDI implementation at Oticon we will review a recent regulatory challenge and how this was met. The implementation team will share their experience from the journey to a solution, followed by a discussion on what immediate challenges lies ahead with UDI maintenance, and what opportunities do medical device manufacturers see for the future.
11:00 - 11:45 The new MDR and IVDR – these are the changes, Micael Johansson, MEDQURE
The CE-marking rules in Europe will be significantly changed for all types of medical device manufacturers, even new manufacturers will be affected since some aesthetic devices with non-medical purpose will be included in the regulation. Listen to major news and recommended actions as way forward.
12:00 - 13:00 Lunch

Afternoon Session: Life Sciences Customer Advisory Board - Building quality into your product development process

13:00 - 14:30 End-to-end complaints to CAPA to effective change
How to increase speed and traceability in design change control
14:30 - 15:15 Global roll-out of an EQMS in PLM
Use Case
15:15 - 15:30 Coffee Break
15:30 - 17:00 Advisory Session
17:00 - 21:00 Optional Tour and Dinner

If you have any questions please don't hesitate to contact Ann Sofie Sjurseth at annsofie.sjurseth@techniatranscat.com or +46 (0)70 921 41 24

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We are sorry, the event has already taken place. Registration will not be possible anymore.