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. 

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.

Lesley Glass is a seasoned Quality professional with a passion for ensuring the safety and quality of products in the Medical Device, Dietary Supplement, Food, and Feed industries. With over a decade of experience, Lesley has demonstrated her commitment to helping clients achieve their Quality Objectives by providing expert guidance and implementing effective frameworks.

Lesley’s journey in the manufacturing industry began in Dietary Supplements, where she held both Regulatory and Quality roles. Her expertise then led her to the Medical Device industry, where she has consistently added value to multiple companies. As a Quality Management System (QMS) expert, Lesley has managed several programs, including Supplier Management, Complaints, CAPAs, and NCRs, among others.

Lesley’s audit expertise has taken her to various locations across North America, South America, and Europe, where she has successfully conducted on-site internal and supplier audits, ensuring that clients’ products adhere to the highest quality and safety standards. Lesley’s audit proficiency surpasses the mere execution of hundreds of audits; her exceptional capabilities have earned her the responsibility of hosting customer, certification body, and regulatory audits with successful outcomes.

Lesley’s industry knowledge and certifications make her a trusted Certification Body Lead Auditor, performing on-site and remote registration and surveillance audits on their behalf. Lesley is fully bilingual in English and Spanish and holds several industry-specific certifications, including Certified Quality Auditor (CQA), Certified Medical Device Auditor (CMDA), and Certified Food Safety and Quality Auditor (CFSQA).