Regulatory

The world of medical device regulations is constantly changing. Our experts can ensure you're equipped with the tools needed to understand, navigate, and apply medical device regulations in an increasingly connected world.

Lead Auditor

AAMI’s 2-day Lead Auditor course teaches participants the requirements of and how to utilize ANSI/AAMI/ISO 13485. Participants will understand best practices of auditing quality managements systems as defined in ANSI/ISO 19011.

Navigating 510(k) and De Novo Requirements

Submitting your medical device for FDA premarket clearance can be overwhelming. This intensive course will give you the preparation you need to complete a 510(k) or De Novo submission, including FDA regulatory pathways, design documentation requirements, and more.