AAMI Virtual Course – Design Control Requirements – Integrating the Quality System Regulation – July 17-19, 2023
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 [...]
AAMI Online Course: Risk-Based Computer Software Assurance Approach for PPQS – July 11th and July 13th from 1:00 pm to 3:00 pm EST
This course is designed for software developers, quality engineers, auditors, process engineers, manufacturing engineers, quality assurance and regulatory compliance personnel, or others involved in the use of Production Process and Quality System Software and responsible [...]
AAMI Virtual Event: Medical Device Software Validation – May 31 – June 2, 2023
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 Online Event – Medical Device Software Validation – May 23, 2023 & May 25, 2023 / 1:00 pm to 3:30 pm ET
The regulatory pace of change is accelerating for the in-vitro diagnostics (IVD) industry. Evolving regulatory standards impact IVD manufacturers, central laboratories, contract research organizations and manufacturers who bring new IVD devices to the commercial market [...]