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

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 ...

Compagnucci, Marcelo Corrales Fenwick, Mark Minssen, Timo and Aboy, Mateo 2024. The Law and Ethics of Data Sharing in Health Sciences. p. 1. Regulators have been more permissive for medical devices ...

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

Food and Drug Administration (FDA) regulations mandate that all medical ... have a moral duty of care in managing the risk of medical IoT devices in their environments to ensure patient safety ...