MCRA’s experts worked with the FDA and can help accomplish everything from creating a complaint process to resolving an FDA warning letter.

Services We Offer

  • Assist in creating complaint process including FDA medical device reporting (MDR) to comply with 21 CFR Part 803
  • Management of recalls in accordance wit 21 CFR Part 806
  • Assist in creating complaint process including vigilance reporting (VR) for CE Mark
  • Improve conforming product process
  • Improve CAPA process
  • Resolve FDA 483's and warning letters
  • Resolve notified body ISO 13485 audit observations


Our Integrated Approach

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.