Companies exporting medical devices to the U.S. must meet FDA Quality System Requirements (QSR) published in 21 CFR 820, plus 21 CFR 803 and 806, covering Medical Device Reporting and Reports of Corrections and Removals.
Gemarmed can assist your company in meeting FDA requirements in a cost-effective and efficient manner including those involving:
  • Design controls

  • Process validation, including master plans and assistance in the development of procedures protocols and reports

  • In-process controls and sampling

  • Complaint handling

  • Change control and change validation

  • Failure investigations

Some companies do not respond adequately to FDA inspection observations or FDA warning letters. If your company has been inspected by the FDA and has been issued a list of inspection findings, or if the inspection has resulted in a Warning Letter, GEMAR can assist you in:
  • Developing an effective corrective action strategy

  • Providing a satisfactory response to the list of inspection findings, and

  • Effectively responding to a Warning Letter, which will expedite FDA review, re-inspection, and full compliance status

Gemarmed has proven experts in the field of quality system regulations and can help you to meet all the requirements and ready your manufacturing facility for the quality system inspection. Contact us for further information.