I will write the software documentation for your medical device

Parte de la información aparece en idioma inglés.
Wessel Kooyman

Bélgica

Hablo Holandés, Inglés

2 pedidos completados

I help you build compliant and secure medical device software faster

Experienced medical device software specialist with extensive expertise as CTO and IEC 62304 Committee Expert. I have led software development teams through FDA and EU regulatory submissions (CE, MDR,...
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For certifying your medical device, you need to produce a number of documents related to the software that's part of the medical device. This includes the Software Requirements Specification (SRS), Software Design Specification (SDS), architecture document, software development plan and many others. Depending on your situation, ISO 13485, IEC 62304, FDA rules and CE MDR (EU) rules may apply. They each have their own document requirements. I can help with them all.

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write the software documentation for your medical device
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write the software documentation for your medical device

Tipo de documento:

Manuales de usuario y de capacitación

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Idioma:

Holandés

•

Inglés

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