Medical Devices
Eurocert offers 10 services under Medical Devices. Contact our team to find the right fit for your organization.
Active Implantable Medical Devices
CE marking and conformity assessment for active implantable medical devices under MDR 2017/745.
Medical Devices CE Certificate
Medical Devices CE Certificate under the EU Medical Devices Directive: classification, technical files, biological and electrical safety testing with Eurocert.
Russia Medical Products Certificate
Roszdravnadzor registration certificate for medical products and devices sold on the Russian market: testing, file preparation and registration process.
REACH Testing Services
REACH testing services for product compliance with EU chemical substance regulations.
Japan Medical Device Certificate
Medical device certification for the Japanese market, including PMDA registration support.
ISO 22716 Cosmetics GMP
ISO 22716 Good Manufacturing Practice certification for cosmetics manufacturers. Apply online with Eurocert.
ISO 14971 Medical Device Risk Management
ISO 14971 risk management certification for medical device manufacturers, aligned with MDR 2017/745 and ISO 13485 requirements.
ISO 13485 Medical Device Quality Management System
What is ISO 13485 and how is it obtained? Apply online for ISO 13485 medical device quality certification and consultancy.
In Vitro Diagnostic Medical Devices Directive (IVD)
IVDR 2017/746 conformity assessment and certification for in vitro diagnostic medical devices.
GMP Medical Devices
GMP certification for medical device manufacturers covering production controls, hygiene, and traceability.
