FDA Medical Device Safety Action Plan: Good or Bad for Medtech?
FDA’s five-pronged Medical Devices Safety Action Plan, revealed in April, has triggered concern by AdvaMed, Johnson & Johnson, and physician specialty groups.
Should Medical Devices Come with Expiration Dates?
Implantable medical devices containing highly sophisticated electronics are lasting longer than before, raising the bar for safety and liability.
Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Is FDA Getting More Cozy with AI?
FDA’s recent approval of stroke detection software paves the way for Artificial Intelligence applications to thrive on the healthcare landscape.
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Get Answers to Your Usability Testing Questions
A live demonstration of formative usability testing at MD&M East aims to share best practices and answer attendee questions.
New EU MDR Regulations and Revamp of the Medical Device Directive
An overview of the key impact points and challenges of European Union Medical Device Regulation.
