Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.

In the medical device industry, usability plays a critical role in ensuring the safety and effectiveness of highly complex medical products. The IEC 62366-1:2015 standard, which focuses on the ...

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. In IEC 60601-1, labeling is deemed "a critical component of a medical device." 1 The ...

"A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the ...

Computer software used in healthcare device applications developed for demographic data gathering, physical examinations or therapies are increasingly part of the regulatory landscape. This article, ...