Blogs

India’s medical device industry is growing rapidly, but with growth comes a greater responsibility to protect patients and ensure ongoing device safety. Under the Medical Device Rules (MDR) 2017, all manufacturers must maintain a robust...

Design verification is one of the most critical steps in medical device development — and one of the most misunderstood. Even seasoned manufacturers face setbacks during this stage, leading to rework, timeline extensions, budget overruns,...

Verification planning is the foundation of compliant medical device design. It starts the moment design inputs are defined and continues through every phase—ensuring that what’s built aligns with regulatory requirements, user needs, and patient safety....