CDSCO releases final guidance document on Medical Device Software: Gireesh Babu, New Delhi The Central Drugs Standard ...

India’s drug regulator CDSCO has issued final guidance on medical device software under MDR-2017, clarifying SaMD vs SiMD rules, Algorithm Change Protocol for AI updates, and licensing processes. The ...

Nine requirements management tools for medical device development ranked by traceability, compliance support, and regulatory readiness for FDA and EU MDR.

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 ...

Digital health innovators who use artificial intelligence (AI) must navigate a range of regulatory risks under Australia's medical device regime. To help them do so, the TGA has recently published ...