Introduction: In the dynamic arena of medical device regulation, clinical evaluations play a pivotal role in assessing the medical devices’ safety, performance, and effectiveness. A crucial component of a comprehensive...

Concept testing is a fundamental Marketing Research methodologyprimarily used to assess customer feedback onnew product/service ideas or concepts. It is a great evaluation tool to determine whether a company should...

Introduction: In the dynamic space of the medical devices world, ensuring their safety and effectiveness post-market is paramount. Post-Market Clinical Follow-Up (PMCF) studies play a pivotal role in this endeavor....

Introduction: The convergence of proactive and reactive methodologies within a post-marketing surveillance (PMS) system can significantly enhance the effectiveness and robustness of medical device monitoring. By harmonizing these approaches, manufacturers...

Introduction: ‘Sufficient clinical data’ is a critical term used in the context of medical device regulations to describe the level of evidence required to demonstrate the safety and performance of...

Introduction: The EU Medical Device Regulation (MDR) is a set of regulations that govern the safety and performance of medical devices in the European Union. The MDR is one of...

Medtech companies are expected to play a key role in the digital transformation of healthcare. Many are already prioritizing building digital capabilities in-house via investing in R&D, business models, and...

Introduction: As the regulatory environment progresses, ensuring the safety, performance, and compliance of In Vitro Diagnostic (IVD) products is of paramount importance. One key aspect of post-market surveillance is conducting...