With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

The new regulations would withdraw the principle of equivalence and require further clinical trials in medical devices, which would especially affect class III devices. The MEDDEV guidance ...

Like all medical devices, implantables are governed by strict regulations to ensure patient safety and manufacturer compliance. Under the US Food and Drug Administration classification system ...

Rather than performing all these activities integrally with the development effort where they add real value in terms of ...

Within the burgeoning healthtech ecosystem, the medical devices market is also witnessing a dramatic shift as policies are being changed to accommodate the high demand. But at the same time ...

On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap).