Traditional Medical Device regulation assumes a fixed product: what’s approved is what ships, indefinitely, until a formal change is filed and reviewed. Adaptive AI and machine learning algorithms break that assumption by...

Although software intended for Medical purposes has been regulated in India since the implementation of MDR, 2017 Rules. CDSCO's Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026), issued on 21 July...

A Recall is one of the few regulatory events where speed of response directly influences both patient safety outcomes and a company’s regulatory standing. Yet many manufacturers only consider their Recall process...

Artificial intelligence is reshaping Pharmaceutical research and development, regulatory affairs, and clinical operations at a pace that few industries have previously experienced. From AI-accelerated drug discovery and predictive Clinical Trial design to...

Regulatory approval is often treated as the finish line. In reality, for Medical Device and IVD manufacturers in India, it marks the start of an equally demanding obligation: Post-Market Surveillance (PMS). Under...