Quality Management


In the U.S., the MDSAP countries, and Europe, similar requirements exist for the development, manufacture, quality and distribution of medical devices. Nevertheless, there are differences in the interpretation and intensity of inspections.

Our services include:

  • Establishment and maintenance of a quality system
  • Analysis of existing processes and documents
  • Identification of gaps
  • Documetation of required procedures
  • Training of employees
  • Support in the implementation of these procedures

 The Capamed Advantage:

  • Efficient and sustainable procedures
  • Efficient and competent preparation and support for ISO certification and FDA inspections
  • Your quality system is certified with ISO 13485 and meets FDA requirements