The landscape of cybersecurity is always changing, which means for medical device manufacturers in the highly-regulated life sciences industry, so, too, are expectations from regulators. By ...

Medical software is the backbone of modern healthcare, supporting electronic health records (EHRs), diagnostic systems, imaging technologies and embedded software in medical devices like pacemakers ...

The guidance sets forth FDA’s 2015 policy on when mobile medical applications qualified as medical devices. But in 2016 the 21st Century Cures Act changed fundamentally the scope of FDA’s oversight of ...

The use of computer systems in medical device manufacturing has rapidly expanded, creating a growing need for modernized ...

Every week, MedCity News highlights the best of its MedCitizens: syndication partners and MedCity News readers who discuss life science current events on MedCityNews.com. Now here’s the best of what ...

Discover how software developers for medical-device OEMs are balancing innovation and safety, and the challenges they face in making it happen. The medical-device industry is rapidly advancing, from ...

In November, the Food and Drug Administration (FDA) held a Digital Health Advisory Committee meeting where it considered ...

The "The EU Regulations for Digital Medical Devices with AI Components A Basket Full of Requirements What Does a Manufacturer Need to Consider? (Dec 9, 2025)" training has been added to ...

Today, a clear path ahead has been set out for the development of new and robust regulations for medical devices in the UK. The new regulations will put patient safety first and help to ensure that ...