The U.S. Food and Drug Administration.

The Food and Drug Administration regulates the safety and efficacy of medical devices, in-vitro-diagnostics and other products. This includes products which are manufactures abroad and imported into the U.S.

The Capamed experts have many years of experience in working with the FDA:

  • Product approval through the FDA
  • Implementation of quality management systems following FDA guidelines
  • Software development and validation following FDA guidelines
  • Qualification of equipment and systems
  • Validation of processes and IT systems

For the medical device and IVD industry we offer consultancy, training, audits and services in these areas:

  • Provide establishment registration and device listing
  • 510k submissions for medical device market clearance
  • Design Control following FDA guidelines
  • Implementing and Auditing Quality Systems (ISO 13485, FDA QSR, 21 CFR 820)
  • Qualification of equipment and systems
  • Process and cleaning validation
  • Software validation and documentation
  • Electronic recordkeeping, electronic signatures (21 CFR 11)
  • Preparation for FDA inspections and dealing with warning letters

The Capamed Advantage:

  • Your product gains entry into lucrative U.S. markets.
  • You achieve regulatory compliance with optimum effort – Saving your company valuable time, money and resources.