Prologue
Peter was running late for two reasons. First, he encountered unexpected heavy traffic and arrived ten minutes late for a crucial meeting with a...
As a medical device company, you are expected to deliver innovative, life-changing medical device(s) while ensuring compliance and achieving true quality. This task bears...
Pre-submission meetings are a good opportunity to interact with regulators, educate them on your technology and gather valuable feedback for your submission.However, if not...
The new US FDA draft cybersecurity guidance requires you to test cybersecurity, but when should you conduct software security testing?
The 2022 draft cybersecurity guidance...
Boston, United States – MicroEJ, the provider of software containers for IoT and embedded devices, announces support of the Managed-C programming language to reinforce...
NMPA published an article on artificial intelligence software for process optimization, illustrating what the clinical applications of the software and how to do software...
IEC 82304, along with the IEC 62304, is an essential standard for software-based medical devices. Although the two IEC standards may look very similar,...
