w
wesselkooyman

Wessel Kooyman

@wesselkooyman
5,0(1)

I help you build compliant and secure medical device software faster

Belgique
Anglais, Néerlandais
Certaines informations sont présentées en anglais.
À propos de moi
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.... Plus d’infos

Compétences

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wesselkooyman
Wessel Kooyman
hors ligne • 

Voir mes services

Applications Web Full stack
I will set up your software development process for medical devices
5,0(1)
De120 $US / projetPlus de détails
Rédaction technique
I will write the software documentation for your medical device
De120 $US / projetPlus de détails

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