Sustainable market success builds on an elaborated claim.
Entering the market and staying ahead of competition is getting more complex every day. The new Medical Device Regulation will further increase the challenges.
We understand. And we can help.
Clinical claim and benefit management is the backbone of each medical device. It administers the benefit in comparison to no treatment and to other established and known good clinical practices.
With our many years of experience, our network of experts and our knowledge of the new regulation, we offer you tailor-made and future-proof solutions.
Claim management is essential if:
You have a new device that you want to launch on the market. With our claim management expertise, we can position your device so that:
- The advantages over competing products are clearly visible
- You can demonstrate and use these advantages in the long-term
- Your new device fulfills the MDR 2017/745 requirements
You have a device that is already on the market and you want to increase its potential. We show you ways to:
- Increase sales compared to competing products
- Visualize and secure its benefits in the long-term
- Meet all requirements for the MDR 2017/745 and be able to keep it longer on the market after 2025
Be ready by 2025
You have an existing product portfolio and want to ensure that it meets the requirements of MDR 2017/745 after May 2024 and can fully exploit its potential:
- We review your portfolio, correct weaknesses and visualize advantages
- We refine your product claims and increase sales opportunities
- We ensure that your portfolio meets the new MDR requirements and thus secure your long-term market access after 2025
Gap analysis for 41medical
A Swiss company that develops and produces solutions for the human musculoskeletal system.
Perform a gap analysis on their post-market surveillance (PMS) system regarding the MDR compliance.
Your solution might be just a phone call away.