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

ANS

I have read the interoperability and security guidelines and the technical specifications that apply to the remote monitoring DMN.

I consult the repository I download the generic line requirements

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 questions about your solution's compliance with the safety and interoperability standards, please contact your notified body.

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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