“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, ...

South China's Guangdong Province has released a regulation, demanding that hotels must ensure that guest rooms are free of ...

Over the past month, Australians have noticed that their iOS devices, including iPhones and iPads, have gained an odd string ...

MedTech Europe’s report reflects a lack of clarity over requirements, rising costs, and decreases in innovation activities.

In 2024, the FDA issued two significant guidance documents on Predetermined Change Control Plans (PCCPs), formalizing a ...

The rate of warnings initiated by the FDA continues to rise in the pharma and medical device industries. Knowing how to best ...

Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product development, ...

Aurora is suing the agency after being denied an exemption from the requirement that drivers place warning triangles when ...

Stakeholders branded the MDR and IVDR rules “unreasonably complicated,” “terrible for EU patients and doctors” and “a mess.” ...

The federation of trusted research environments for genomics and health. Whilst trusted research environments are not yet ...

In recent years, new regulation has been top-of-mind for medtech companies wishing to continue marketing their products in ...

It’s incredibly rewarding to build in the medtech space, but some data suggests the average medical device requires $31 ...