Bryan Brosseau’s experience has been forged over 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 and MDSAP 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.
