The bill has received bipartisan support for removing barriers and accelerating innovation in medical devices, drugs and biologics.
From glucose monitors to heart monitors, the mobile technology market for medical products continues to expand.
There are several steps you can take to ensure your mHealth app is keeping patient health data safe and secure.
As wearable technology within the medical device industry heats up, FDA makes some clarifications on which products fall into general wellness and low-risk categories.
Unique factors are involved when designing adhesives for the face and other fragile parts of the skin.
Susan Alpert, principal of SFA Consulting, explains the role of clinical evidence for combination products and the complexities at play.
What are the challenges faced by OCP?
Assessing the Manufacturing Readiness Level of your new product can help identify risks and opportunities to cut time to market.
The comprehensive approach to human factors considers how a product operates alone, interoperability in larger settings, and data management.
With the increased complexity of devices, a streamlined approach to managing product development risks and documenting compliance is challenging but perhaps more important than ever.