AAMI Virtual Training – Integrating Risk Management into the Product Lifecycle – June 28-30, 2021
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 Virtual Training – Process Validation Requirements & Industry Practices – April 14-16, 2021
Process Validation Requirements & Industry Practices is a 3-day, virtual training that will provide attendees with practical tools and techniques for process validation requirements to meet FDA’s Quality System Regulation, the ISO 13485:2016 Standard, and recognized Process [...]
AAMI Virtual Event – Medical Device Software Validation – March 31 – April 2, 2021
During this 3-day training, learn how to develop and validate medical device software in an ever-changing landscape of regulations and technology. This class will ground you in all the relevant regulations, standards and guidance and [...]
AAMI Virtual Course – Quality System 21 CFR 820 and ANSI/AAMI/ISO 13485 Navigating Regulatory Requirements – offered virtually March 22-24, 2021
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 [...]