Software Medical Device

Medical Device Cybersecurity Testing: Methods, Requirements and Regulatory Compliance Medical device cybersecurity testing has moved from a recommended best practice to a mandatory regulatory requirement. Both the FDA and EU MDR now explicitly require manufacturers to demonstrate, through documented testing evidence, that their devices are adequately protected against cybersecurity threats throughout the entire product lifecycle —…

Introduction IEC 62304:2006 is the internationally recognized standard providing a framework for the development, testing, and maintenance of software used in — or as — medical devices. With the rapid growth of software-based technologies in the medical field (including Software as a Medical Device, SaMD), understanding and correctly applying this standard has become essential for manufacturers, software developers,…