Medical software solutions are important to healthcare technology because they help with the monitoring, management and control of patient’s information and medical health. Devices that leverage ...

Quality Management Systems (QMS) are integral for medical device manufacturers as they ensure adherence to regulations and help in producing top-quality products. Utilizing the right QMS software ...

On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap).

These include deficiencies in Software Bill of Materials (SBOMs ... beyond regulatory compliance—they’re reframing the medical device industry’s approach to cybersecurity.

Venudhar Rao Hajari has built a successful career in the areas of Medical Device Development Quality Assurance, Software ...

which is not legally enforceable but “describe the Agency’s current thinking” suggests that manufacturers could provide a plan for updating AI-powered software in medical devices that would ...

The Ministry of Food and Drug Safety approved the software medical device for depression probability assessment (product name ...