Medical Devices & IVD Services
Regulatory Affairs
Establish a regulatory pathway
Program your MDR / IVDR transition
Obtain CE mark
Prepare 510k or PMAs
Clinical Affairs CRO
Design clinical strategy aligned with R&D
Get approval for clinical investigation
Monitor clinical investigation
Document your CER
Quality Assurance
ISO 13485:2016
QSR – FDA
QMS architecture
Supplier controls
Internal audits
CAPA, documentation control
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 servings companies of all sizes ranging from academic startups to majors.
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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
