123456789

Medical Device

IVD Regulatory Assistance

Pharmaceuticals

Medical Device

IVD Regulatory Assistance

Pharmaceuticals

GEMARMED supports Medical Device startups and established companies in achieving their regulatory and QA business goals by helping them navigate through the challenging and changing regulatory maze, achieve compliance, pass the most rigorous inspections, and bring products to approved status in the target markets.

CONTACT US
To certify medical devicesTo certify an IVD medical deviceTo define medical devices developmentTo establish Quality SystemTo certify combination productsTo pass an inspectionTo overcome hurdles
CE Marking and the MDR-Gemarmed-Regulatory service for medical device
In Vitro Diagnostics and the IVDR | Gemarmed
DHF Medical Device Consulting | Gemarmed
QMS for Medical Devices and IVD medical device | Gemarmed
EU MDR 2017:745 Compliance for DDC | Gemarmed
ready with an internal and external audit | Gemarmed
Person Responsible for Regulatory Compliance (PRRC) | Gemarmed
Book 30 Minute Free Consulting