An excellent overview of the challenges and benefits of the Microservices architectural style of software application development.  While many of the factors discussed by the author (Dr. André Fachat, published January 30, 2019), these same factors can affect the safety and efficacy of a medical devices using this style.  The article consists of two parts:...Read More

As more “software as a medical device” (SaMD) applications are developed and marketed, there has been an increased focus on what activities and documentation are required for compliance with US medical device regulations and applicable ISO standards.  Along with the rise of SaMD has come the emergence of supporting organizational, management, and production activities that...Read More