Tag: IEC 62304

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Cybersecurity’s Impact on Health Systems

We are currently seeing significant technological advances in medical devices, hospital networks and patient care. As medical devices become increasingly interconnected via the Internet, hospital networks, other medical devices, and smartphones, there is an increased risk of exploitation of cybersecurity vulnerabilities, some of which could affect a device’s performance, functionality and safety to the patient....
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IEC 62304 Software Development Life Cycle

Avoid Common Medical Device Software Development Life Cycle Pitfalls

Learn Potential Software Development Life Cycle Pitfalls to Pay Attention To IEC 62304 is the international standard that defines software development life cycle requirements for medical device software. IEC 62304 was developed from the perspective that product testing alone is insufficient to ensure patient safety. It provides a common framework for medical device manufacturers to develop...
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Life Science Webinar

Is Your Medical Device a Secret Safety Risk?

WHEN: Thursday February 26th WHERE: Your office TIME: 1.30pm – 3.00pm REGISTER HERE Compliance with IEC 62304 is required for all electromedical devices where basic safety is dependent on software or firmware. But many device companies remain unaware that the devices they manufacture must meet this standard. That may be because there’s confusion stemming from a key...
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Understand how the FDA uses the IEC 62304

IEC 62304 Safety Requirements FDA medical device recalls are on the rise. An increasingly active FDA, coupled with the rise in software components for medical devices is adding up to new challenges for manufacturers. Given this reality, it’s important to understand how the FDA uses the IEC 62304, an international standard developed that, among other things,...
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