In recent times collection of real-world evidence has gathered everyone’s focus and poses great potential to provide valuable insight into medical device safety and performance, especially for legacy devices. In

In recent times collection of real-world evidence has gathered everyone’s focus and poses great potential to provide valuable insight into medical device safety and performance, especially for legacy devices. In

In recent times collection of real-world evidence has gathered everyone’s focus and poses great potential to provide valuable insight into medical device safety and performance, especially for legacy devices. In

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.

‘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 a

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

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

The European Union Medical Device Regulation 2017/745 (EU MDR) has brought significant changes to the regulatory landscape for medical devices in Europe. Conformity assessment plays a crucial role in ensuring the

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