Regulating Point of Care Printed Devices
Point of care 3D printing of medical devices has abundant potential. However, many regulatory uncertainties remain.
Tag Archives: liability
AI/ML-based SaMD: Trends in Litigation
This pioneering area of technology comes with new risks and questions of liability.
More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey
A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.
Liability Risks and Litigation Defenses for COVID-19 Tests: Provider and Laboratory Liability
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
Asia 2020 Device Regulatory Update
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.
Liability Risks and Litigation Defenses for COVID-19 Tests: Five Lessons from Past Product Misdiagnosis Cases
Part II reviews some lessons learned as we try to predict the trajectory and defenses to COVID-19 test cases.
Medical Device Software & Products Liability: Interoperability (Part III)
How software is changing the legal landscape for medical device manufacturers.
Medical Device Software & Products Liability: The Homefront (Part II)
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.
Mesh Lawsuits Shine Light on Material Sourcing and Selection
Having the right internal material science expertise, along with aligning material specs with device outcomes is essential.
Six Concepts to Navigate Manufacturer-Sponsored Clinical Trials
What you need to learn before thinking about seeking Medicare reimbursement for a clinical trial.
What you need to learn before thinking about seeking Medicare reimbursement for a clinical trial.
