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.
Introduction to Combination Products and Regulations: a Risk-Based Approach
From software as a medical device, to the growing field of biologics, to the enhancement of medical devices with medicinal substances, the scope of products considered combination products continues to expand. Join industry-renowned instructor Susan Neadle to deepen your understanding of the ever-evolving regulatory landscape of combination products, including navigating and applying requirements and recommendations from 21 CFR Part 4, and TIRs 48 and 105, as well as gain familiarity with interpretations within the emerging global marketplace.