The new Medical Device Regulation (MDR) introduces many new requirements on the medical device market. It represents a major challenge for medtech companies. Plantvision has an experienced multidisciplinary team, covering a broad range of resources, expertise, and services, who can provide you with continuous support over the implementation and transition period to MDR.Customized MDR services to meet your specific needs:
- MDR seminars & workshops
- Gap analysis
- Gap analysis workshop
- Transition plan MDD to MDR
- RA support during transition and/or market access process
- Plantvision Academy courses and customized training
An important area where Plantvision can provide support is in helping your organization gain a good understanding of the new regulation and its requirements. This can be achieved through tailormade courses or workshops, where we help you to identify your company’s specific needs. We can help you to efficiently define your transition plan by carrying out a thorough MDR gap analysis in order to identify where your company currently fails to comply with MDR. This includes a detailed follow-up report with recommendations for what actions should be taken.
You can also ensure continuous support during your transition process through our Compliance Partner service, which provides fast and efficient access to experienced consultants. Our consultants are equally capable working in English or Swedish.