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 ...

FDA has an impressive collection of ongoing digital health initiatives, and the regulation of software and hardware has evolved greatly since smartphones and tablets were launched about a decade ago.

We missed this earlier: On October 21, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare (MoHFW), released draft guidelines for granting licences ...

Autonomy isn't free; rather, it's financed by sophisticated oversight systems that enable safe and reliable autonomous ...

The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on Medical Devices Software, under the Medical Devices Rules (MDR), 2017, to bring in specific regulatory ...

Value stream management involves people in the organization to examine workflows and other processes to ensure they are deriving the maximum value from their efforts while eliminating waste — of ...