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 used to validate Process and Quality System using a software lifecycle process. Program Objective Participants will learn about the software [...]
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 capability and product characteristics.” Folks, that's asking you to keep score. But regulatory compliance is not the only issue. Any organization that [...]
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 manufacturer's cleaning processes for processing medical devices. This standard applies to all medical devices that require cleaning before each clinical use of the device. During this training, the design of [...]
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, and trends in health technology standards and regulations. This October, the global medical device standards community will come together in-person [...]