AAMI Event In Person and Virtual – Design Control Requirements – Integrating the Quality System Regulation – November 30 to December 2, 2022
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 Event – Sampling Plans-Made Easy – November 16 and 17, 2022
Event Overview To the casual observer, Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother? The key advantage [...]
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 [...]