Tag Archives: safety

Biological Evaluation of Medical Devices

By Jan Peeters, Paul Malinovski
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The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.

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UDI: What You Need to Know About Timelines, Compliance and Submissions

By Yasser Mohammed
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The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.

The legislated FDA Unique Device Identification regulation is a single device identification system that is invariable, absolute, standardized, and globally reconciled. All medical device manufacturers will be required to comply with the new UDI approach. Here’s some information for you to get started.

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Meeting Your Electrical Safety and Quality Requirements

Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.

Compliance with 60601-1 is not just about electrical safety; it is also about addressing mechanical, structural and environmental factors, and following a process to address usability, risk management and software development.

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