The clock is ticking for MDR.
The Medical Device Regulation (MDR) is fully applicable since May 26th 2021, and no later than May 26th 2024, all medical device software must be compliant with MDR. To make your medical device software MDR compliant, we recommend you to:
- Update or create your QMS
- Update or create your technical documentation
- Create a submission to a suitable notified body to be able to CE-mark the software
Key2Compliance can help with this process. Our team of specialists have extensive knowledge in all aspects of the development of medical devices. We can make sure that your medical device software is compliant before the time runs out.
We can now offer a special package containing:
- MDR and MDSW training
- GAP Analysis – QMS and technical documentation
Follow the link below to learn more about how we can help you get ready for MDR!