Thought Leadership

“Developing Medical Device Software,” new Med Device Online article series by Sterling Medical Devices While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device software companies should consider preparing for a potential expansion of this case practice … Continued

Software can be an essential component of your medical device, whether you’re designing a new product or improving the functionality of an existing one. Medical device software continues to change and expand across many types of medical devices. Patient safety … Continued

The Internet of Things (Iot), the continual proliferation of mobile medical devices, and the growing amount of data in hospital systems are trends medical device manufacturers should closely follow. Similarly, medical device manufacturers should track cybersecurity trends. Just last year … Continued

The medical technology (medtech) sector is ablaze with change as a result of the increased usage of mobile apps. Today, legislators, media outlets, and decision-makers in industry are increasingly talking about the FDA’s role in regulating the growing wave of … Continued

A better approach than limiting the FDAs scope along certain criteria through legislation would be to allow the FDA to be more nimble and empowered, with oversight to prevent regulatory abuse.   The 21st Century Cures Act is the talk … Continued