Medical Devices and Engineering

As a manufacturer of medical devices, you bear great responsibility. The product has to guarantee greatest possible benefits, while meeting high legal requirements. Our experts give you the assurance you need that you meet both these requirements. As an internationally recognized "notified body" and present in over 60 countries, we can also help you get quick and easy access to markets worldwide.

Tested Medical Device

Tested Medical Device

Market Your Products More Effectively with Voluntary Certification.

Medical Products (MDD)

Medical Devices Directive (MDD)

Medical Products Help Save Lives.

IEC 60601-1

IEC 60601-1: Electrical Medical Equipment

Are Your Electromedical Products Compliant and Safe?

Japanese Pharmaceutical Affairs Law (PAL)

TÜV Rheinland Japan is registered as a Third Party Certification Body with the MHLW to perform certification for PAL

In-Vitro Diagnostic (IVD) Devices

In-Vitro Diagnostic Devices (IVD)

We Can Test and Certify Your Quality Management System and Products.

Active Implantable Medical Devices (AIMD)

Active Implantable Medical Devices (AIMD)

Conformity Assessments for Your Active Implants.

International Approval for Medical Devices

Medical Devices: International Approval

Your Gateway to New Markets.

ISO 13485 Certification

Validating Your Quality Management System.