CQOE and Funky Math

FDA's Digital Health Software Precertification (Pre-Cert) Program has proposed various measures that might be used to determine whether a software developer in the Software as Medical Device (SaMD) space has demonstrated that the quality of its operations is sufficient to provide reasonable assurance that its SaMD product is safe and effective. Culture of quality and organization excellence (CQOE) is something like the quality system as defined by the Quality System Regulations (QSR) (21CFR820), but it is not identical to the QSR. They share the philosophy that process is a measure of product, but regular devices still have to undergo review before marketing. CQOE might in some way reduce or eliminate such review. To the extent that CQOE is used instead of QSR compliance, a broad-spectrum manufacturer has to deal with two different quality systems—one for pre-cert eligible software and the more traditional QSR for the rest of their portfolio.   The proposed excellence elements of CQOE are Patient Safety, Product Quality, Clinical Responsibility, Cybersecurity Responsibility, and Proactive Culture. These elements are further defined as:   Patient Safety: Demonstration of a commitment to providing a safe patient experience and to emphasizing patient safety as a critical factor in all decision-making processes. Product Quality: Demonstration of a commitment to development, testing, and maintenance standards necessary to deliver SaMD products at the highest level of qualit...
Source: MDDI - Category: Medical Devices Authors: Tags: Software Source Type: news