I have read the interoperability and safety guidelines for digital medical devices.

Prerequisites

The solution must be CE marked.

01. I identify the base documentation that concerns me

Start-up

ANS

I have read the safety and interoperability guidelines

I consult the repository

02. I'm upgrading my solution

I'm bringing my solution into line with the standards

Point of attention: Updating your digital device may have an impact on your CE marking.

Need help?

If you have any difficulty in ensuring that your solution complies with the safety and interoperability reference framework, you can address your questions to your notified body.

I download my complete guided tour and the checklist summarizing all the actions I need to take.

Mon parcours guidé remboursement de ma solution de télésurveillance