Quality system regulation

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. MCRA’s quality system services include the following:

  • 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

To contact a quality assurance expert at MCRA, call 202.552.5800 or email

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services

People & Expertise



Quality Assurance

Mr. Biggins has over twenty years of experience in the area of Quality Systems and Manufacturing beginning as a Quality Engineering Manager. Mr. Biggins is an expert at Quality Management Systems, specifically in the areas of Corrective and Preventive Action (CAPA), Customer Complaints, Design Control Read More

PH: 202.552.5800