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

A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). A suite of guidance ...

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 ...

As the health care sector embraces AI, the incoming administration confronts some pressing challenges about what to regulate, ...

The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...

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

The European Commission has presented a new action plan to enhance the cybersecurity of the healthcare sector amid a rise in ...

Innovative Health Sciences (IHS) proudly announces a remarkable milestone in its journey to introduce the Insignis™ Infusion System into the global market. The Company successfully passed the ...

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

Firefighters are urging people not to mix and match their lithium-ion battery chargers due to the increasing risk of a fire ...

Garmin (NYSE: GRMN) today announced the ECG App is now available to customers in Australia and the European Union with a ...