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.

 

QUALITY MANAGEMENT

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 AFFAIRS

Regulatory submissions to access new markets and expand existing ones.  A Brosseau Consulting regulatory strategy means a quick and compliant path to market.

RAPS Regulatory Affairs Certification (US).

GENERAL CONSULTING

Due diligence, product development, project management, and business plans require perspective from seasoned quality and regulatory experts.  Let Brosseau Consulting be your on-call expert.

Over 18 years of interdisciplinary experience.