Approval | Certification
QM | QA | RA


We support you in product approval and product certification for all markets around the world. With our specialists in quality management, quality assurance and regulatory affairs, we ensure that your product successfully meets all the requirements and receives approval for market entry from the very beginning.

We keep an eye on the approval criteria throughout the entire development process.

Reaching Goals With DITABIS
QM | QA | RA

We support you:

  • Preparation and review of the technical documentation
  • Verification of the device developed for the customer
  • Product classification and identification of relevant standards
  • Product labelling and packaging review
  • Risk analysis
  • Performance of technical approval incl. necessary pre-tests

Our Focus:

  • CE conformity especially for IVDR | MDR
  • Risk management according to ISO 14971
  • Handling and support of safety testing (CB procedure)
  • Handling and support of EMC testing
  • Support and supervision of FDA certification
  • Support in the preparation of technical documentation in accordance with MDR/IVDR

We would be happy to give you individual advice on the approval of your product within a personal conversation, or as part of a workshop.

Simply send us an inquiry. We will get back to you as soon as possible.