New Delhi: In a move to align India’s regulatory framework for medical device software with global standards, the Central Drugs Standard Control Organization (CDSCO) has released new draft guidelines ...

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 ...

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner.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 ...

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...