Point of care 3D printing of medical devices has abundant potential. However, many regulatory uncertainties remain.
This pioneering area of technology comes with new risks and questions of liability.
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.
How software is changing the legal landscape for medical device manufacturers.
This second article in the three-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.
Having the right internal material science expertise, along with aligning material specs with device outcomes is essential.
What you need to learn before thinking about seeking Medicare reimbursement for a clinical trial.