AAMI Training – Navigating 510k and De Novo Requirements – March 1-4, 2022
This 4-day course will navigate the 510(K) clearance process and De Novo classifications requests for United States (U.S.) and global Medical Device Manufacturers and regulatory affairs leaders to improve the ability to bring new and [...]
AAMI Course – Integrating Risk Management into the Product Life Cycle – February 9-11, 2022
This comprehensive 3-day course for medical device manufacturers presents risk management concepts used throughout the quality system that can help your organization meet FDA, ANSI/AAMI/ISO 14971 and ANSI/AAMI/ISO 13485:2016 requirements for risk management. This course [...]
AAMI – Introduction to Combination Products and Regulations: A Risk-Based Approach / Expert Susan Neadle – February 2, 7, 9, 14, 16, 21, 2022 / 1:00-3:00 pm ET
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 [...]
AAMI Course – Quality Systems Regulation 21 CFR and ISO 13485 – January 31, 2022 – February 4, 2022
This 4.5 day course is the culmination of years of consensus development on the part of a respected group of quality system experts from leading device manufacturers, the FDA, industry consultants, and members of International [...]