Quality Management

ISO 13484. FDA QSR. 21 CFR 820.

In the U.S. 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.

Another fundamental difference is that compliance with the FDA regulations cannot be certified. FDA inspectors review the quality system through on-site inspections relying heavily on several documents that are not required to the same extent by ISO 13485 (Device Master Record, Device History Records, Complaint Files).

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