All tasks of engineering will be needed for the verification and validation of your medicine products.

The innovative creation and construction of your medicine product is our work.

Of course we comply with the regulatory standards and because of that we make your work easier and help you to verify

and validate your medical products and support you in:


  • risk management of products: EN ISO 14971 with different top-down and bottom-up methods
  • process risk management: EN ISO 14971 e.g. as pFMEA
  • requirements phase with tracebility
  • usability engineering with EN 62366-1:2017
  • planning and conducting of formative and summative evaluations
  • constructions according to relevant standards and the latest state-of-the-art  
  • prototype production in consideration of human blood compatibility and biocompatibility
  • design verification and validation
  • validation/ qualification of equipment, software and processes
  • documentation




We are developing and designing your medical device according to the requirements of MDR in compliance with relevant international standards and we support you in verifying and validating your medical devices. Gain an impression of what we have developed with our partner piu products (c).

Please convince yourself of our expertise:

We are looking forward to your inquiry.