Medical device makers want to improve products' Time-to-Market while complying with an ever increasing regulatory complexity. When well managed, rapidly changing regulations are opportunities to be used to build a competitive advantage.
During this half-day event we highlight the recent regulatory changes introduced by the new MDR and IVDR, how they impact medical device development practices, and how to turn these challenges into opportunities.
Many medical device companies who want to handle these challenges efficiently have introduced Product Lifecycle Management (PLM) as a business transformation approach introducing a cross-functional IT platform supporting the complete process from idea to product launch – offering increased leverage on a modular platform, reduced lead times and reduced cost.
In this event you will learn why medical device manufacturers have chosen this approach – often bridging engineering, regulatory and QA functions, what benefits are targeted, and how global medical device manufacturers are handling these challenges.
When: November 28th 11:30 - 17:30 + Apero
Where: Lehmann Riverside, Spinnerei-Lettenstrasse, CH-8192 Zweidlen-Glattfelden, Switzerland
12:00-12:40 Introduction (while lunch is served)
12:40-13:20 Turning regulatory complexity into a competitive advantage with PLM (TechniaTranscat)
13:20-14:00 The new MDR and IVDR – these are the changes (TÜV SÜD)
14:30-15:10 Using PLM to accelerate the delivery of innovative, safe and fully compliant medical devices (Dassault Systèmes)
15:10-15:50 Examples of compliant operational solutions to create competitive long-lasting company advantages (William Demant Holding)
16:10-16:50 End-to-end traceability in PLM from Complaints to CAPA to effective Change (TechniaTranscat)
16:50-17:30 Advisory Session and Conclusions of the day (TechniaTranscat)
Presentations at this event will be in English.
If you have any questions please don't hesitate to contact Annelie Uvhagen.
TechniaTranscat GmbH | Am Sandfeld 11c | DE-76149 Karlsruhe | Germany
direct +46 (0) 73 37 72 480