Problem Resolution

Medical device manufacturers are required to comply with FDA regulations regarding how device issues are recorded and resolved. MCRA’s experts worked with the FDA and can help accomplish everything from creating a complaint process to resolving an FDA warning letter. MCRA’s services include:

  • Assist in creating complaint process including FDA medical device reporting (MDR) to comply with 21 CFR Part 803

    Management of recalls in accordance with 21 CFR Part 806

    Assist in creating complaint process including vigilance reporting (VR) for CE Mark

    Improve nonconforming product process

  • Improve CAPA process

    Resolve FDA 483's and warning letters

  • Resolve notified body ISO 13485 audit observations

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