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 we are your point of contact for the following:

  • Conformity assessment procedures
  • Quality management systems
  • Tests of medical devices
Medical Devices (MDD)

Medical devices (MDD)

Learn more about the MPG and the medical device directive

Processing of medical devices

Reprocessing of medical devices

QM system for Sterile Services Departments in hospitals


IVD

In-Vitro Diagnostics (IVD)

Everything you need to know about IVD

Active Implantable Medical Devices

AIMD

CE marking for active implantable medical devices


International Approvals for medical devices

International Approvals

Conquer world markets with us


ISO 15378:2006

ISO 15378

Primary packaging standard for pharmaceutical products

ISO 13485

EN ISO 13485

QM system for medical device manufacturers


With a presence in over 60 countries we know and maintain a watching brief on the constantly changing requirements in the most important international markets. That is your key to swift and uncomplicated market access – all over the world!

Challenge us. We are at your service!

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