FDA Quality System

21 CFR 820. QSR. Medical Devices.

The U.S. FDA establishes requirements for the design, manufacturing, quality control, and distribution of medical devices. Federal law requires manufacturers (or 510k owners) of most medical devices to implement a quality system that meets the Quality System Regulation (QSR) found in 21 CFR Part 820. We have designed and implemented quality management systems for a wide range of medical device companies, with a broad spectrum of medical device types and manufacturing processes (e.g. implants, active medical devices, software, devices to be ingested, non-active devices, etc.).

Our services include:

  • Establishment and maintenance of a QSR compliant quality system
  • Analysis of existing processes and documents
  • Identification of gaps in relation to the QSR
  • Documetation of required SOPs
  • 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
  • FDA compliance and ISO 13485 certification