I will set up your software development process for medical devices

W
wesselkooyman
W
wesselkooyman
Wessel Kooyman
5.0
5.0
set up your software development process for medical devices
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set up your software development process for medical devices
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Full Screen
set up your software development process for medical devicesset up your software development process for medical devicesset up your software development process for medical devices

About this gig

For software development for medical devices, the regulatory framework is ISO 13485 and IEC 62304. I'm an expert in setting up your processes and documenting them, and then helping your team produce the documentation needed for medical device software development. I can also fine tune and improve your existing processes. I've worked with both EU MDR and FDA regulations.

  • Programming language

    • JavaScript

  • Expertise

    • Algorithms & Data structures
    • Debugging
    • Design
    • Databases

  • Frontend framework

    • React.js
    • Vue.js
    • Semantic-UI
    • Svelte

  • Backend framework

    • Django
    • Laravel
    • Node.js

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

Reviews

1 reviews for this Gig
5.0

(1)
(0)
(0)
(0)
(0)
Rating Breakdown
  • Seller communication level
    5
  • Recommend to a friend
    5
  • Service as described
    5
Sort By
Most relevant
  • M
    image-docs

    magnordahl

    NO

    Norway

    5

    Prompt and professional advise! Thank you!

    Helpful?
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Reviews

1 reviews for this Gig
5.0

(1)
(0)
(0)
(0)
(0)
Rating Breakdown
  • Seller communication level
    5
  • Recommend to a friend
    5
  • Service as described
    5
Sort By
Most relevant
  • M
    image-docs

    magnordahl

    NO

    Norway

    5

    Prompt and professional advise! Thank you!

    Helpful?
    Yes
    No

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