Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national and international regulatory requirements.

Software in the healthcare industry has come a long way over the past 20 years. Medical device companies, like most life sciences companies, were a bit hesitant to incorporate software and automation ...

Medical devices have to be designed so that people can use them easily and reliably. Human factors considerations have gained increased attention since the release of FDA's guidance document, Medical ...

Mobile device management creates a standard setting for corporate owned mobiles, tracks their location, and enforces security. Systems can also manage BYOD. Find out the best MDM system. Businesses ...

Forbes contributors publish independent expert analyses and insights. Steven covers accessibility and assistive technologies. The Food and Drug Administration (FDA) made a big announcement on Thursday ...

FDA approval is widely regarded as a benchmark of quality for medical devices. However, concerns persist regarding its regulatory framework for digital mental health devices. This perspective article ...

Kimberlee Leonard has 22 years of experience as a freelance writer. Her work has been featured on US News and World Report, Business.com and Fit Small Business. She brings practical experience as a ...

Bill McColl has 25+ years of experience as a senior producer and writer for TV, radio, and digital media leading teams of anchors, reporters, and editors in creating news broadcasts, covering some of ...

Deploying software to large fleets of Linux-based devices is a complex and critical process that requires careful planning and automated execution. Start with these best practices. The internet of ...

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be posting a series ...