Coding guidelines are intended to promote source code that is understandable, maintainable, testable, and error-free. This article describes the regulatory requirements for coding guidelines and provides specific examples.
IEC 82304 is now available. This is a good reason to take a closer look at this standard for “health software products.”
The Health Breach Notification Rule defines when health records providers have to report which security issues to whom, within what time frame and in what form. This article provides a brief overview of the requirements of the US Federal Trace Commission (FTC).
The Federal Trade Commission (FTC) is an US agency that aims to ensure compliance with competition law and consumer protection. This article explains the circumstances that require you (e.g., as a medical device manufacturer) to comply with the FTC requirements and the specifics of these requirements. The case of Lumosity shows how radically the FTC…
Details“Will a software audit take place?” is a question that reached me via our micro-consulting. ‘And can I avoid a software audit by choosing the appropriate software safety class?” At first, I didn’t realize exactly what ‘software audit’ meant or what the exact concern was. But then I understood and found the question to be…
Details