Blogs

Introduction: Why Performance Evaluation Is Where IVDR Decisions Are Made Many IVD manufacturers assume that once performance studies are completed, regulatory approval is largely procedural. Under IVDR, this assumption is risky. In practice, Notified Bodies...

Introduction: A Game-Changer for India’s MedTech Sector The Indian government’s Scheme for Strengthening of the Medical Device Industry is a landmark initiative designed to boost domestic manufacturing, cut import dependence, and promote clinical evidence generation...

Introduction: When Study Completion Isn’t the Finish Line For many IVD manufacturers, completing a performance study feels like crossing a major regulatory milestone. Budgets are spent. Timelines are met. Internal teams move on to the...