Inquiry on Medical Device Certification Support for .NET MAUI

[spulverail]

Dear .NET MAUI Team,

I hope this message finds you well.

I am writing on behalf of a medical device development company that is currently exploring cross-platform mobile frameworks for the next generation of regulated medical devices (Class IIa under MDR and FDA guidelines).

We are particularly interested in understanding whether .NET MAUI could meet the stringent requirements of medical device software certifications (IEC 62304, ISO 13485, FDA 510(k), MDR CE Marking).

Specifically, could you kindly clarify:

• Whether .NET MAUI provides or plans to provide documentation or support that could assist in certifying a medical application developed with your technology?
• Are you aware of any existing or in-progress projects where .NET MAUI has been successfully used to develop software for Class II or Class III medical devices?
• Does your roadmap include features, documentation, or services oriented towards high-assurance or regulated industries, particularly healthcare and medical devices?

Any available technical documentation, case studies, or contacts for further discussion would be greatly appreciated.

Thank you very much for your time and consideration. We would be delighted to continue the conversation should there be opportunities for deeper collaboration.

Looking forward to your reply.

Best regards,
Sébastien Pulvérail
TechnoConcept France

[ghost]

In case you will not get any answer, check Copilot AI. It gave me a good answer for your question that might get you into the right direction.

[MerSpyro]

I dont really think asking a hallucinating AI bot is a good idea when dealing with anything medical including ISO certification.

[ghost]

@MerSpyro CoPilot found Medical Device Software Development (MDSW), maybe you can search for relevent links to find more information.

I was searching for "Medical Device Certification Support + Xamarin" and found Software as a Medical Device (SaMD) Compliant: 25+ years of experience and Approval & certification of software medical devices (MDR).

[clarkstephen619-bot]

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