Regulatory Consulting, Regulatory Inspection Management, Regulatory Management Capacity, Regulatory Submissions, Regulatory Submissions 510(K), Regulatory Submissions 513(G)Who We Are: Meet The Team

Comprised of a group of over forty senior quality, regulatory, operations and manufacturing professionals, Barile and Associates provides a broad range of support for the medical device, pharmaceutical, human tissue and biotechnology industries. We have a great depth of technical expertise with capabilities in design and manufacturing engineering, science, statistics, quality systems, process design and validation, computer technology deployment and validation. We are experts in US FDA and international regulatory requirements. We have offices in North America, the Middle East, Asia and Europe.


Michael Barile, Founder and Managing Partner
Michael Patrick Barile has over twenty five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the senior quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and practical hands-on expertise with a wide variety of challenges over a diverse range of product technologies.  A recognized expert in risk management, software and process validation, continuous improvement methods and quality systems, he lectures worldwide in seminars and for various trade groups

Robert Humphrey, Senior Quality Engineering Consultant
Mr. Humphrey is an experienced engineer with over twenty years of experience in design verification & validation, test engineering and quality engineering. Amongst his accomplishments, Mr. Humphrey has designed and implemented test methodologies for new products that have reduced both cost and time to market, developed company wide policies and procedures to ensure compliance to cGMPs, QSRs, ISO 60601 and ISO-9001/9001-3 requirements and devised metrics to evaluate software development and verification efforts. Mr Humphrey is also an Instructor at the University of Phoenix in the school of Business and Technology and at Lake Washington Technical College in the Information Technology / Computer Applications Department.

Andrew Snow, Senior Engineering Consultant
Mr. Snow has over twenty five years of experience managing quality, design and development for large medical device companies, start-ups and as a contract manufacturer. He has proven expertise in quality systems, risk management, design controls, requirements management, software life cycle processes and reliability engineering. Mr. Snow has developed risk management processes for software and hardware based medical devices using ISO 14971 and has leveraged this expertise to help companies improve compliance, product quality and reliability. He has also championed numerous lean and six sigma efforts to reduce cycle time and improve quality.

Dr. Rainer Boenigk, Senior Quality Assurance and Regulatory Affairs Consultant
Dr. Rainer Boenigk has over thirteen years of experience in medical devices, in-vitro-diagnostics and pharmaceuticals. Over the course of his career, Dr. Boenigk has been both Vice President of Quality and Regulatory Affairs at the executive management level with global responsibilities and as an individual contributor to various international quality assurance & regulatory affairs functions. He has also been a Plant Manager. Dr. Boenigk´s areas of expertise include quality assurance, regulatory affairs, crisis and risk management, global FDA compliance, lean manufacturing of medical devices, pharmaceuticals (sterile fluids), in-vitro-diagnostics, electromechanical equipment and sterile/non-sterile consumables.

Dr. Christopher Gribbin, MD, Consulting Physician
Dr. Christopher Gribbin has over twenty five years as a practicing physician and expert in the field of Radiology. Dr. Gribbin is currently an Interventional and General Radiologist and Attending Radiologist at Robert Wood Johnson University Radiology and a Clinical Assistant Professor of Radiology, University of Medicine and Dentistry of New Jersey, RWJ Medical School. Dr. Gribbin has authored numerous medical publications, presented at conferences and is a member of six medical societies including the Society of Cardiovascular and Interventional Radiology.

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