Medical Devices & IVD Services

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Regulatory Affairs

Establish a regulatory pathway
Program your MDR / IVDR transition
Obtain CE mark
Prepare 510k or PMAs

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Clinical Affairs CRO

Design clinical strategy aligned with R&D
Get approval for clinical investigation
Monitor clinical investigation
Document your CER

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Quality Assurance

ISO 13485:2016
QMS architecture
Supplier controls
Internal audits
CAPA, documentation control


Digital Health

Development support of Software
as a Medical Device
Software classification & validation
Cybersecurity assessment
Support with GDPR-HIPAA

Our services cover all steps of product development, from initial project idea to certification or regulatory clearance. With sites in Switzerland, Germany, Denmark, Belgium and USA, Medidee is a global services supplier serving companies of all sizes ranging from academic startups to majors.

We are recruiting

Please follow this link to visualize our current job opportunities

Business cases

Medidee supports Clients by composing highly customized services bundles aligned with Clients needs. Hereafter, some examples of business cases that Medidee handles regularly. Still, we feel ready to build any new combination that would match your needs

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