Regulatory & Clinical Affairs

Medical technologies are strictly regulated in the European Union and on an international level. Manufacturers must meet various requirements and standards before a medical product can be legally placed on the market. The regulatory requirements frequently change and are becoming more and more complex, thus making the approval process increasingly demanding. Our certification and regulatory experts understand the challenge of developing medical products for global export and can help to ensure the compliance and conformity of your product and speed up its market launch.

Bertrandt Medical has many years of experience in the validation of equipment, processes, and systems used in a wide range of applications for medical products. We apply our experience in the regulation of medical products and in-vitro diagnostics to ensure that all the necessary documentation, certification, and compliance requirements for your product are complete, thus creating the conditions for a successful market launch. Our service package is rounded off by flawless technical documentation. 

To make sure that your medical product complies with the regulatory requirements and standards, our engineers and scientists understand the technical procedure and will work closely with you to tailor validation projects precisely to your needs.

Examples of our services in Regulatory Affairs

  • Creation and updating of technical documentation
  • Revision of your technical documentation to meet the requirements of the Medical Device Regulation (MDR)
  • Support in creating a risk management file according to EN DIN 14971
  • European and international approval of medical products
  • FDA approvals and coaching
  • Planning for the necessary tests and coordination of the laboratories
  • Training courses on regulatory topics
  • Usability

Our services in Clinical Affairs

  • Creation of clinical evaluations and support for clinical studies 
  • Planning for the necessary tests and coordination of the laboratories
  • Creation and revision of the biological report
  • Creation of PMS and PMCF
  • Creation of an SSCP report


Your Contact

Kirsten Schild

Head of Bertrandt Medical GmbH