AAMI Event / Keeping Score – Measuring Product and Process Capability – October 26, 2022
A famous sports coach once said: “If you are not keeping score, you are just practicing.” The FDA’s Quality System regulation says that manufacturers “shall establish and maintain procedures for… verifying the acceptability of process [...]
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 [...]