AAMI Course (Offered Virtually) – Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485 – February 8-10, 2021
This intensive 3 – day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during [...]
Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485: Navigating Regulatory Requirements – November 2-6, 2020
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 [...]
2020 Virtual IIoT & Smart Manufacturing Conference – October 27, 2020 – 9 am to 5 pm EST
This one-day virtual event will encompass topics regarding advances in connectivity, automation, and security within the operational context of hybrid manufacturing applications across multiple vertical industries. To register and for more info: https://isaautomation.isa.org/2020-iiot-smart-manufacturing-conference/
AAMI Virtual Event – Integrating Risk Management into the Product Cycle – October 12-14, 2020
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 [...]