Introduction One of the most debated questions in regulatory affairs today is whether equivalence is still a viable strategy under EU MDR. Some say equivalence is effectively dead. Others argue it...

Introduction “State of the Art” (SOTA) is one of the most frequently used—and misunderstood—concepts in clinical evaluation. Most manufacturers think it means: “the latest and most advanced...

Introduction Biocompatibility has long been treated as synonymous with testing.Cytotoxicity, sensitization, irritation—run the tests, compile the reports, and move forward. But under modern regulatory...

A Practical Guide for Medical Device Manufacturers Introduction Post-Market Clinical Follow-up (PMCF) has become one of the most important—and often misunderstood—requirements under the EU Medical...

Introduction Demonstrating clinical equivalence under the EU Medical Device Regulation can look simple at first glance. Many manufacturers assume that if another device already exists on the market...

Introduction Bringing a medical device to market requires more than just technical development and bench testing. One of the most critical aspects of regulatory approval is demonstrating that the...

Introduction Submitting a 510(k) to the U.S. Food and Drug Administration is a significant milestone for medical device manufacturers. However, many companies assume that once the submission is filed...

Introduction Bringing a medical device to the U.S. market requires regulatory clearance — and for most moderate-risk devices, that pathway is the 510(k). The 510(k) process is often described as...

Avoiding mistakes in a 510(k) submission is less about fixing problems later and more about building a strong regulatory strategy from the beginning. The U.S. Food and Drug Administration clears...