AAMI Virtual Event – Production and Quality System Software (Nov22) – November 3-4, 2022
This course is designed to understand what is and what is not production and quality system software that is required to be validated by FDA and ISO 13485 and will show the methods and tools [...]
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, [...]