We pave the way to approval

We have already successfully supported a large number of medical device manufacturers in meeting the requirements for CE certification and thus enabling market access within the European Union.

Through our contact with Notified Bodies, we know exactly what the requirements are and how the processes work. Thus, we can plan and implement appropriate approval strategies. Thanks to our many years of experience, we can support you in the market access of your products in order to accelerate this process in the best possible way and to implement the conformity assessment procedures that are suitable for you.

CE marking in compliance with the European Directives for Medical Devices 93/42/EEC and 90/385/EEC for Active Implants ensures broad access for your product to EU and EFTA countries.

In addition, a marking based on sound Technical Documentation is a strong and reliable basis for the approval and classification of your medical device in many countries outside (and within) the European Union.

Our services

  • Product classification and selection of appropriate conformity assessment procedures
  • Preparation of technical documentation
  • Compliance testing of the essential requirements
  • Selection of Notified Body testing laboratories and performance of relevant coordination activities
  • Definition and approval of combination products
  • Support in market surveillance and creation of an appropriate vigilance/observation and notification system for your products

Call: +49 9123 1529250
Mail: info@be-on-quality.com

Office adress, Visitors adress, Büroanschrift:
be-on-Quality GmbH
Bahnhofstrasse 85
91233 Neunkirchen am Sand

Headquarter of  be-on-Quality GmbH
Lilienstrasse 33, 91244 Reichenschwand