The U.S. Food and Drug Administration.

The Food and Drug Administration regulates the safety and efficacy of medical devices, 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

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

  • 510k submissions for medical device market clearance
  • Design Control following FDA guidelines
  • Implementing and Auditing Quality Systems (ISO 13485, FDA QSR, 21 CFR 820)
  • Software validation and documentation
  • 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.