PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is warning device manufacturers that new regulations for software-based medical devices may have changed the classification of ...

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 ...

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Late last month, India’s drug regulator came out with a draft guidance document to regulate “medical device software” — this move, the medical device industry agrees, could not have come sooner.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

The Central Drugs Standard Control Organisation (CDSCO) has launched a new risk classification module on the drug regulator's online system for medical devices in order to simplify the regulatory ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...