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