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 [...]
AAMI Course – Industrial Sterilization for Medical Devices – January 18-21, 2022
Industrial Sterilization for Medical Devices is a comprehensive 4-day course covering essential information on sterilization technologies and methods, sterilization standards, FDA requirements, critical factors in product design and product release decisions, and much more. Participants [...]