I will write the software documentation for your medical device

Wessel Kooyman

Belgium

I speak English, Dutch

2 orders completed

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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About this Gig

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

Document type:

User & training manuals

•

Reports

Language:

Dutch

•

English

Delivery style preference

Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.

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