I will do the software testing and verification for your medical device software

W
wesselkooyman
W
wesselkooyman
Wessel Kooyman
do the software testing and verification for your medical device software
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do the software testing and verification for your medical device software

About this gig

We do software verification according to IEC 62304 - including writing a formal Software Verification Plan, test cases, unit tests for the code, a formal Software Verification Report.

  • Expertise

    • Debugging
    • Design
    • Source control
    • Testing procedures

Get to know Wessel Kooyman

Wessel Kooyman

I help you build compliant and secure medical device software faster

5.0(1)
  • FromBelgium
  • Member sinceAug 2022
  • Last delivery2 years

  • Languages

    English, Dutch
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.

Other Software Development Services I Offer

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