The law requires “manufacturers” and those holding/owning the 510k to implement a quality system that meets QSR requirements found in 21 CFR Part 820. MCRA can help you create a quality system or modify your existing quality system to meet the requirements found in the QSR. Additionally, we have operations experts that can help you save money in your manufacturing process by optimizing your manufacturing efficiencies. MCRA’s quality assurance manufacturing services include:

  • Perform validations from planning through completion
    (Process, Software, Design, Cleaning, Sterilization, Packaging)

  • Assist with the implementation of lean manufacturing
    improvement system

  • Process mapping and improvement

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