Brosseau Consulting provides quality and regulatory services for the medical device and biologics industries. We access new markets, instill culture of quality, and ensure regulatory compliance for your organization.
From implementation to improvement and auditing to administration, Brosseau Consulting is a proven partner in Quality Management Systems for EU MDR, ISO 13485, AATB, FDA, and international regulatory compliance.
Certified ISO 13485:2016 Lead Auditor.
Regulatory submissions to access new markets and expand existing ones. A Brosseau Consulting regulatory strategy means the greatest value for your organization.
RAPS Regulatory Affairs Certification (US).
Due diligence, development, project management, and business plans require perspective from seasoned quality and regulatory experts. Let Brosseau Consulting be your on-call expert.
18 years of interdisciplinary experience.