MCRA’s experts have the knowledge and expertise to help make your system compliant with U.S. requirements.

Services We Offer

  • Quality System Regulation (QSR)
    Does the quality system meet the requirements? Assist in developing a plan to eliminate the gaps found during an assessment
  • Create a Quality System to meet QSR
  • Create/review Device Master Records (DMR) and Device History Records (DHR)
    These records are required to meet QSR Confirmation that all processes required to manufacture the product are listed in the DMR and the DHR

 

Our Integrated Approach

To ensure that medical devices sold in the U.S. market are safe and effective, the FDA requires that manufacturers follow Good Manufacturing Practices as part of its Quality System Regulation (QSR: 21 CFR Part 820). Domestic and foreign medical device manufacturers must put in place a quality system that addresses the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices sold in the U.S. MCRA’s experts have the knowledge and expertise to help make your system compliant with U.S. requirements.