The last few years have brought unprecedented challenges, opportunities, and evolution for companies of all sizes. The small and middle market is no exception. In fact, the pandemic served as an a…
In recent years, decentralized and hybrid clinical trials have emerged as promising alternatives to traditional clinical trials. Decentralized clinical trials (DCTs) refer to studies in which part…
The Health Sciences Authority of Singapore will implement the UDI system, a global system for tracking and identifying medical devices. The core components of Singapore’s UDI system are in accorda…
In recent years, Automaton has become more powerful and its applications to business have increased dramatically. As a result, companies and business functions, including Regulatory, that hadn’t s…
With EU MDR timelines extended, some brief analysis for manufacturers:
Devices benefitting
The extension provisions apply to a device if:
It was certified by a notified body under the Me…
