Quality assurance

Medical device companies must adhere to strict FDA quality assurance (QA) requirements to ensure product consistency and safety. Failing to meet quality assurance standards costs small and large device firms both time and money. Our quality assurance team, many of whom have worked for notified bodies, combine in-depth knowledge of the nuances of this complex arena with strong relationships with real agencies to guide you through the processes for product review, approval, and regulatory compliance. We reduce your compliance stresses and help bring your device to market, and then maintain quality assurance requirements with adherence to standards to stay on the market.

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