Establishing an MDR-compliant quality management system and appropriate documentation is essential for the approval and conformity assessment of medical devices. Ideally, these processes should be taken into account and implemented in the development phase.

Non-active medical devices

The normative regulations governing market access for medical devices are set out in the MDR, Regulation (EU) 2017/745. However, the implementation of the required quality management system in accordance with EN ISO 13485 for the individual product requires a particularly high degree of care, specialist knowledge and experience.

We offer consulting services for the development of efficient, transparent quality management systems and the associated documentation, conduct audits, assess nonconformities and optimise QM processes.

 

Consulting for manufacturers of medical devices during development

  • Consulting regarding the requirements of the various medical devices classes
  • Support for the development of quality management systems and technical documentation
  • Preparation for conformity assessments

Consulting for manufacturers of medical devices that are on the market

  • Support during audit preparation
  • Execution of mock audits
  • Quality management system optimisation
  • Supplier audits