From development to
long-term market success

For over 20 years, we have successfully supported our customers with projects related to every aspect of the development and manufacture of medical devices. Here, you can learn more about the current focus of our work. Of course, it is important to note that our customers and the sector as a whole are continuously growing and evolving – and so is our range of services!

Quality management and auditing

  • Design and strategic alignment of QM systems
  • Initial setup and implementation of QM systems or further development in line with new or amended laws and standards
  • Internal auditing, supplier auditing

Conformity assessment and technical documentation

  • Strategic planning of device certification and authorisation
  • Support throughout the development process, verification and validation planning, technical documentation
  • A hot topic: Reassessment of products in accordance with Regulation (EU) 2007/745 on medical devices

Global registration and authorisation

  • Creation of authorisation documentation
  • Expanding the QM system
  • Administrative tasks regarding registration

Occupational safety

  • Occupational safety specialist
  • Hazard assessments in accordance with the German Ordinance on Industrial Safety (BetrSichV), German Ordinance on Hazardous Substances (GefStoffV), German Ordinance on Biological Substances (BioStoffV), and more.
  • Occupational safety and health management systems

What makes us tick

Since our beginnings and as time has gone by, providing our customers with expert, individual advice has always been our top priority. When doing so, we have always ensured that practically-based, effective solutions are at the heart of what we do. Today, we are proud of our many long-standing business relationships, which are testament to the success of our services and successful collaborations. Our aim is to remain true to these principles in the future, continuing to help you achieve your goals with our innovative ideas and solutions.

Michael Schrack