Many medical device companies develop software using a traditional waterfall methodology in which each step is taken in sequence: requirements, design, implementation, verification, and validation ...

As discussed in the final guidance, FDA anticipates that the agency and industry will need up to 60 days after the publication of this guidance to operationalize the recommendations discussed; however ...

PCCPs allow device manufacturers to implement preapproved modifications to their devices in lieu of obtaining separate authorizations for each significant change prior to implementation. A PCCP ...

The Food and Drug Administration today released two guidance documents; one related to low-risk wellness products (including ...

The 2023 State of Cybersecurity for Medical Devices and Healthcare Systems report, a collaboration of the Health Information Sharing and Analysis Center with Securin and Finite State, examined the ...

Medical device manufacturers are increasingly implementing integrated mobile software and device applications to automate the inventory management process. By doing so, companies can better track ...

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 ...

Quick Summary Managing large fleets of connected devices across diverse environments? Discover the 10 best IoT device management software solutions for enterprises in 2025 that help onboard, monitor, ...

Autonomy isn't free; rather, it's financed by sophisticated oversight systems that enable safe and reliable autonomous operation at scale.