Effective and more efficient example!Read More

#software #capa … Should a #medicaldevices manufacturer treat potential software design issues any different than any other product #quality issue?Read More

What is CAPA?   Corrective and Preventive Action (CAPA) is a fundamental quality process for medical device manufacturers including SaMD.  From the regulations it is really not that complicated.   21 CFR 820.100 reads: (a) Each manufacturer shall establish and maintain procedures for implementing corrective and preventive action. The procedures shall include requirements for: (1)...Read More

You are likely aware of the CAPA process overall and how it fits in to the quality management system for a medical device manufacturer or supplier.  Just the name itself, corrective and preventive action, describes one of the core values of quality management.  Surely we are all motivated to identify and correct problems and issues...Read More

The pdf at the link provided is a reprint of an article entitled “Understanding CAPA Requirements in a Software Context” authored by Alan Kusinitz, Managing Partner of SoftwareCPR, for the AAMI Biomedical Instrumentation and Technology journal published in the Spring of 2004. AAMI – AKusinitz CAPA – article 0504Read More