MDR initiative to help customers meet regulatory requirements

2018/11/23.

The new Medical Device Regulation (MDR) introduces many new requirements on the medical device market. It represents a major challenge for medtech companies. For many, the prospect of transitioning from the current Medical Device Directive (MDD) to MDR can feel overwhelming.
PlantVision has an experienced multidisciplinary team, covering a broad range of resources, expertise, and services, who can provide customers with continuous support over the implementation and transition period to MDR.

Support for transitioning from MDD to MDR

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 QA/RA Partner service, which provides fast and efficient access to experienced consultants.

All of our MDR solution areas can be customized to meet your company’s specific needs:

  • “Getting started” interactive seminar
  • Gap analysis
    – Gap analysis workshop
    – Transition plan MDD – MDR
  • RA support during transition process (QA/RA Partner service)
  • PlantVision Academy courses and customized training
Cecilia Fällman
Cecilia FällmanSenior Consultant & Team Leader, PlantVision Compliance
Tel: +46 (0)72 717 10 67

Contact me to find out more about how we can support your organization, or if you would like to arrange a free MDR seminar.

Look out for more MDR updates in the coming weeks!