w
wesselkooyman

Wessel Kooyman

@wesselkooyman
5.0(1)

I help you build compliant and secure medical device software faster

Bélgica
Inglés, Holandés
Parte de la información aparece en idioma inglés.
Sobre mí
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.... Lee más

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wesselkooyman
Wessel Kooyman
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Aplicaciones Full Stack Web
I will set up your software development process for medical devices
5.0(1)
DeUSD 120 / proyectoMás información
Escritura técnica
I will write the software documentation for your medical device
DeUSD 120 / proyectoMás información

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