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

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

medical devices often don't have built-in tools for software upgrades when a security patch becomes available. Healthcare CIOs face challenges in capturing a comprehensive inventory of medical and ...

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

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

On December 16, 2024, the SEC announced settled charges against Becton, Dickinson and Company for misleading investors about risks associated with ...

Many non-US medical device manufacturers pursue FDA 510(k) clearance to access the lucrative US market, the largest medical ...

such as medical devices, cars, and some open-source software. Devices can display the E.U.’s CE mark to communicate that they are abiding by the CRA. Regional consumers should then have less leg ...