Founded to support entrepreneurs and industry with contract quality and regulatory support.  We are committed to patient safety, an efficient strategy, and success for the life-saving and life-improving ideas of your organization. 

 

Through repeated successes for numerous medical device and biologics organizations, Bryan has developed a transparent and informative approach to regulatory and compliance matters.  Get the expertise, work ethic, and dedication you need without a full-time commitment or human resource hassles.

 

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Bryan Brosseau

Founder & Principal Consultant

Mr. Brosseau’s experience has been forged in almost 20 years in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, he hones in on the necessary requirements of a project to ensure quality and compliance without impeding progress. Prior to operating Brosseau Consulting LLC on a dedicated basis, Bryan managed quality management systems for numerous companies and has obtained regulatory approvals for products across a wide range of therapy areas.  Having obtained many domestic and international regulatory approvals for medical devices and biologics, his thorough understanding of the regulatory maze means a clear road map for your success.

Bryan’s creative solutions have been effective in resolving FDA 483s and warning letters, addressing compliance and operations challenges, creating compliant and convincing technical marketing material, and getting medical devices and biologics to market quickly. Bryan received his Bachelor’s Degree in Biology from the University of Georgia, maintains a Regulatory Affairs Certification (US) from the Regulatory Affairs Professionals Society, and is a certified ISO 13485:2016 Lead Auditor.

Mr. Brosseau's primary areas of expertise include regulatory submissions, regulatory compliance, quality systems management and technical support. He also provides project management and due diligence support and excels at both discrete technical activities and high-level management due to his extensive experience in the medical device and biologics industries. With a varied and in-depth knowledge of quality and regulatory requirements, Bryan will ensure a timely path to market, the highest standard of quality, and regulatory compliance for your company.