Implementing IEC 62304 for Safe and Effective Medical Device Software, PART 2

The reliability of the embedded software used in medical devices and the risk associated with it has become a vital concern. IEC 62304, “Medical device...

Implementing IEC 62304 for Safe and Effective Medical Device Software — PART 1

FDA’s introduction to its rules for medical device regulation states: “Medical devices are classified into Class I, II, and III. Regulatory control...

The Next Industrial Revolution and What It Could Mean for Medical Device Manufacturing

The next industrial revolution is on its way. It is bringing innovative technologies that are available and proven and placing them in the modern...

Meeting the Chronic Disease Care Challenge with Secure Medical Devices

The Centers for Disease Control and Prevention reported that, in 2005, 133 million Americans suffered from at least one chronic disease. The magnitude of the effect of...

Managing Mechatronic Challenges in Medical Electronic Product Development

Most medical electronic systems now depend on combinations of hardware and software, forming elaborate mechatronic systems that both monitor and regulate patient...

Selecting a Partitioned OS for a Radiation Therapy System

As medical devices increase in functionality, they need more robust and complex embedded software. Handling that complexity usually requires the software to utilize an operating...