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TEAM

The experience and professionalism of our leadership is the core driver of MCRA's specialized services in regulatory, clinical, healthcare compliance, reimbursement and quality assurance. The team brings tremendous industry expertise, transaction leadership, and knowledge to our clients, and provides the backbone for the culture that makes our firm unique.

Patrick Biggins

Vice President,
Quality Assurance & Manufacturing

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 (including Design Change) and Production and Process Control, including process validations based on the GHTF guidance. Mr. Biggins has assisted organizations in creating and implementing a QMS based on the FDA QSR. He has completed reviews of DMRs, process validations and instituted DHR systems at a number of small, medium and large, including multi-site and multi-national, firms. Mr. Biggins has planned and implemented systems to meet MEDDEV guidance and MDD requirements. He has implemented multi-site registrations for ISO 13485 since 2002.

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