w
wesselkooyman

Wessel Kooyman

@wesselkooyman
5.0(1)

I help you build compliant and secure medical device software faster

Belgium
English, Dutch
About me
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, MDD) and guided companies through ISO 13485 audits. I create and review compliant documentation including requirements, architecture, SOUP/OTSS, detailed specifications, and risk management files aligned with ISO 14971. I also set up eQMS and ALM solutions to streamline workflows, enable automated traceability, and help teams deliver secure, audit-ready software efficiently.... Read more

Skills

w
wesselkooyman
Wessel Kooyman
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See my services

Full Stack Web Applications
I will set up your software development process for medical devices
5.0(1)
From$120 / projectMore details
Technical Writing
I will write the software documentation for your medical device
From$120 / projectMore details

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5.0

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  • Seller communication level
    5
  • Recommend to a friend
    5
  • Service as described
    5
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