Medical Devices ? In Trustworthy Hands
Are you looking for a competent partner to lend a helping hand as you face the challenges and markets of the future? Then we are just what you need. Precisely Right.

You as a manufacturer bear a heavy responsibility, especially for medical devices. The product must not only deliver the best possible benefit but also fulfill each and every statutory requirement. Our neutral statement is your safeguard.

As an internationally recognized notified body TÜV Rheinland is your point of contact for the following:
- Conformity assessment procedures
- Quality management systems
- Tests of medical devices

Medical Devices (active/non-active)
Quality is vital – trust us. Are you looking for a partner who provides reliable support? Then come to us – we are a “Notified Body” for all medical devices and in-vitro diagnostics. We certify products and QM systems for the Eu-ropean and international market. We provide you with experience, expertise and service.

CE conformity for active and non-active medical devices - Service at a glance
As a manufacturer you must declare the conformity of your medical devices with the requirements of the medical directives with the CE mark. Depending on the product’s risk category, the involvement of a “Notified Body”, which you commission for example with the conducting of an EC type-examina- tion, the assessment of a design dossier or the auditing of your QM system, is absolutely essential.

In cooperation with you, we conduct the necessary compliance assessment procedures for your devices and your company. You are thus quickly provided with your “admission ticket” to the countries of the EU.

We are pleased to offer you testing of special and voluntary market requirements as well.

Ce conformity for in-vitro diagnotics
We are also a “Notified Body” for the field of in-vitro diagnostics (IVD). You can have your devices tested and certified by us in accordance with the various procedures of the European IVD Directive.

GM mark - a visible display of valued added
The GM mark stands for a comprehensive quality and safety statement by a neutral, independent testing authority. Convince your customers that you are doing more than what is absolutely necessary in order to guarantee the safety and quality of your devices.

Also in questions about Ergonomics and Electromagnetic compatibility (EMC) we are the right contact.

Simply give us a call – We look forward to hearing from you!