Comply all the time, not just when FDA announces an inspection.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
Don’t ignore the changing medtech landscape; it will continue to affect product design and manufacturing. A discussion with Kenneth Fine about design challenges.
Design freedom, increased accuracy, and customization, are fueling growth.
One town in Pennsylvania is preparing for the Papal visit by equipping its various sites with defibrillators.
The latest cybersecurity threat reveals how an insulin pump is vulnerable to hackers.
FDA issues safety communication alert for Hospira’s Symbiq Infusion System.
FDA’s perspective on human factors and usability engineering has evolved.
From glucose monitors to heart monitors, the mobile technology market for medical products continues to expand.