Medicon Valley Alliance have the pleasure to invite you to the 11th meeting within the Medtech Network. The meeting will be hosted by MVA member company Key2Compliance and will focus on Clinical trials in Medtech. We are looking forward to host a physical event in Copenhagen with insightful presentations followed by networking.
The medical device field is evolving and evidence from clinical investigations is becoming even more important. Device manufacturers are required to both specify and justify the level of clinical evidence needed to demonstrate safety and performance.
As a manufacturer, you will need to consider the clinical development plan as part of your regulatory strategy. A significant question to pose is how to assess the need for clinical investigations and post-market clinical follow-up studies. While this may be a fairly straight-forward task for new devices more careful considerations are needed for legacy devices.
In this MVA network meeting we will share knowledge on clinical development and important aspects to consider when planning clinical investigations. Examples from device manufacturers will be presented and you will also get an update on the most recent interpretation of MDCG 2020-6 as well as ISO14155:2020.
Date: 14th of September, 2021
Time: 14.30 – 17.30
Host: Key2Compliance
Venue: Medicon Valley Alliance, Auditorium, Arne Jacobsens Alle 15 , 2300 Ørestad City, Copenhagen
Program:
| 14.30 – 15.00 | Arrival – registration and networking |
| 15.00 – 15.05 | Welcome and introduction by MVA and Key2Compliance Petter Hartman, CEO, Medicon Valley Alliance Åse Ek, Senior consultant and trainer, Key2Compliance |
| 15.05 – 15.10 | HØIBERG – European Patent Attorney Peter Borg Gaarde, Partner, HØIBERG European Patent Attorney |
| 15.10 – 15.30 | Setting the scene – the role of clinical data and how to assess the need for clinical investigations Maria Lindgren, Director Clinical Development, Key2Compliance Robert Iosif, Team Lead Clinical Development, Key2Compliance |
| 15.30 – 16.00 | The newest revision of ISO 14155 and it’s relation to MDR Birgitte Berg, Senior Trial Project Manager, Novo Nordisk |
| 16.00 – 16.20 | Clinical strategy and clinical development plans – how to adjust to MDR requirements Sofia Jonhede, Clinical Affairs Director, EU/RoW, Xvivo |
| 16.20 – 16.40 | How to build an evidence generation plan for the product life cycle, examples from Stryker Hanna Schlyter, Senior Director Clinical Affairs, Trauma & Extremities, Stryker |
| 16.40 – 17.00 | Questions and discussion |
| 17.00 – 17.30 | Networking |
Deadline for registration is 10th of September, 2021
For more information please contact Sofia Norås sn@mva.org
The Network
MVA Medtech Network gathers the region’s medtech industry to create new partnerships and business opportunities. Joining the network is free of charge for Medicon Valley Alliance members interested in gaining new insights, sharing experiences and networking with like-minded organisations. Non-member organisations and companies are welcome to attend one network event to evaluate membership.
| Host of the event: | Sponsor of the event |
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| MVA Medtech Network is managed by | In Collaboration with | |
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