AAMI Key Updates: AAMI/ANSI ST98 (October 2022) – October 25-27, 2022
Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices (ANSI/AAMI ST98) is a new, published standard. It replaces AAMI TIR30 and provides requirements to validate the medical device [...]
AAMI Event – 2022 International Conference on Medical Device Standards and Regulations – October 17-19, 2022
For more than three decades, AAMI has hosted the AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation; the premier event for medical device experts who want to be up-to-date on the latest developments, changes, [...]
AAMI Online Event – Valid Statistical Procedures for Process Validation – Made Easy – September 28-29, 2022
A big challenge for Process Validation is to establish objective evidence that a process is capable of consistently delivering quality product. The goal of these two webinars is demonstrate how valid statistical techniques meet this [...]
AAMI – Understanding TIR45: Agile Methods for Medical Device Development – September 21, 23, 29, and 30, 2022 – 1:00 pm – 3:00 pm ET
This two-part, four-session series begins with an introduction to AAMI TIR45, Guidance on the Use of AGILE Practices in the Development of Medical Device Software, and then addresses many of the key concepts and recommendations [...]