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

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 ...

Metals, polymeric materials, and refractory materials are being replaced by technical ceramics due to their toughness, chemical inertness, and high-temperature capabilities. This is one of the primary ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

There are an increasing number of fake medical devices and in vitro diagnostics (IVDs) being introduced into the medical market. In 2010, WHO reported that 8% of all medical devices in circulation are ...

The Union Health Ministry introduced SAHI and BODH to enhance AI deployment in India's healthcare. SAHI provides national guidance, while BODH validates AI solutions. The Central Drugs Standard ...

On February 2, European Union Member States endorsed the world’s first comprehensive legal framework regulating artificial intelligence in the EU. The EU’s Artificial Intelligence Act (AI Act) applies ...