Medical Devices & IVD Services
Regulatory Affairs
Regulatory Affairs

Establish a regulatory pathway

Program your MDR / IVDR transition

Obtain CE mark

Prepare 510k or PMAs

 

Clinical Affairs CRO
Clinical Affairs CRO

Design clinical strategy aligned with R&D

Get approval for clinical investigation

Monitor clinical investigation

Document your CER

 

Quality Assurance
Quality Assurance

ISO 13485:2016

QSR – FDA

QMS architecture

Supplier controls

Internal audits

CAPA, documentation control

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.

SUPPORTED INDUSTRIES
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