NAVIGATE THROUGH MEDDEV, MDR & ISO TERRITORY SAFELY.

To keep your ideas for medical technology innovations from bursting before they reach the market.

 

We are not "THE CONSULTANTS" but engineers, physicians and QM experts with established technical expertise based on numerous international development, production and approval projects.

Our customers – ranging from small and midsize enterprises to large corporate groups – benefit from this expertise in our consulting projects:

  • We meet the very highest quality, safety and process standards, for example in the conceptual design, realisation and approval of life-sustaining systems.
  • We meet the various requirements of the respective national approval authorities for you.
  • Starting from concept and planning towards creation of clinical evaluation reports and conduction of clinical investigations/studies: We establish the clinical evaluation for you.
  • From QM light to QM XXL, we offer tailor-made solutions for your enterprise and products.
  • We are also happy to support you on site in your company.

 

A description of the individual consulting services offered by us can be found here: