FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the principles of software validation. The scope of the document covers, inter alia, the aspects...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the software validation principles. Table of Contents The document provides additional...
FDA The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the content of premarket submissions for device software functions. Table of Contents The document is...
FDA The present article details FDA guidance on software testing, including tests performed by the manufacturer (software developer) regarding potential changes to the software. The basics of software testing are described in the initial article. The Food and Drug...
Australia and Oceania The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published a questions-and-answers document addressing the most important aspects related to software-based medical devices. The document is intended to...
