In medical-device software, an update isn’t just a new feature — it can directly affect patient safety. Every code change in a surgical-laser system must be fully traceable to its verification and ...
Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...
The "Clinical Evaluation of Medical Device Software and Software as a Medical Device Training Course" training has been added to ResearchAndMarkets.com's offering. This course will provide a clear ...
The FDA released their updated guidance on Cybersecurity in medical devices: Quality System Considerations and content for Premarket submissions at the end of June in 2025. In this guidance the FDA ...
As the biopharma space gets more competitive and the days of blockbuster drugs seem further in the rearview, biopharma companies are investing in digital to find new and innovative ways to ...
Hacking pacemakers and insulin pumps is mostly hype; thankfully the scary stories are just that, scary possibilities that could supposedly happen if attackers were to target vulnerable devices. Some ...
Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner. The ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback