Transition from MDD to MDR without losing focus or control
Why you need to make the MDR transition now
The MDD-MDR Transition is one of the biggest challenges in the medtech industry for the coming years. New rules have been defined to tighten controls to ensure safety and efficacy of novel and legacy medical devices within the EU markets. If you don’t have a MDR compliant product, you cannot market it for EU customers.
Preclinical data need to be presented as part of the MDR technical documentation to conclude on general safety and performance requirements (GSPR). Legacy device manufacturer find it often difficult to summarize relevant development results.
We help you to analyze the current status of your documentation and how much re-testing needs to be done. Once you have conclusive pre-clinical and clinical data you are able to demonstrate MDR conformity of devices. This ensures conformity with current technical standards and creates transparency on efforts and costs of your device.
Dr. Veit Otto
Dr. Michaela Hajek
Dr. Yuriy Lebed
How we make the MDR transition smoother for you
1
Your product is not MDR compliant yet.
2
We identify the reasons of non-compliance.
3
Get a clear picture of your MDR project.
4
We help you get all the required documents and solve any critical issues to become MDR compliant.
5
Your product is MDR compliant.
All the necessary actions for the MDD-MDR transition
are being taking care of
So that you can focus on your business
Getting an independent view on your identified problems
Understanding the underlying causes for project delays
Risk analysis and evaluation
Managing activities for managing MDR product compliance
Organize re-engineering activities to re-verify / re-validate your product according to regulation
Reviewing and updating technical documentation
Analyse clinical data and set up PMS Activities
Organize PMCF studies and data collection
Plan and execute initial clinical trials
Include relevant MDR processes in your QMS
Carry out PMCF studies
Get your medical device ready to market
Many business owners get headaches just thinking about the coming MDR. Do you have every step of the transition figured out? If you don’t, we will help you make the transition so that you can market your device in the EU.