ECRI releases its top 10 list of health technology hazards for 2018.
Recognizing that additive manufacturing is an emerging technology, the agency is providing an outline of its current thinking about the technical aspects of AM processes.
Effectively leveraging the intellectual assets of your business requires a holistic approach to IP protection.
This second article in the 4-part series looks at the use of software in medical devices in non-clinical settings, particularly the home environment. It addresses software’s role in the home healthcare trend, explains the software-related risks that arise from home-use products, and discusses what manufacturers can do to make these products safer.
How do you find meaningful signals in the middle of masses of noise, correctly interpret those signals and apply them for a useful purpose?
As standalone software becomes increasingly sophisticated, a number of regulatory bodies have begun to draft separate guidelines to ensure quality control, expedite product approval, and improve patient access to new technologies.
Global sports medicine is predicted to grow to around $35 billion by 2022, with the Asian market growing at a compound annual growth rate of nearly 7 percent.
The removal of communication barriers and ambiguity allows technology providers to focus on their own inherent system benefits.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.