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
QSR – FDA
QMS architecture
Supplier controls
Internal audits
CAPA, documentation control

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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.