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Standards and Compliance

EU Commission Extends Transitional Provisions for In Vitro Diagnostics

The Commission of the European Union (EU) has amended key transitional provisions for certain...

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

Medical Devices Increasingly Vulnerable to Cyberattacks

Despite ongoing publicity around the need to secure systems and equipment against the threat...

EU Commission Updates Biological Safety Standards Applicable under MDR

The Commission of the European Union (EU) has updated the list of standards that...

FDA Publishes Discussion Paper on 3D Printing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a discussion paper on the...
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Navigating the “Safety Hierarchy”

The safety hierarchy is a flexible concept that can be helpful in deciding on a final product design. But it can also be a trap for the unwary design engineer. This article will discuss the safety hierarchy concept, how do you comply with its requirements, and what are the problems associated with it?

EU Commission Regulates Electronic Instructions for Medical Device Use

The Commission of the European Union (EU) has also published requirements for providing medical...

FDA Updates List of Recognized Standards for Medical Devices

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international...

EU Commission Sets Out Regulations for Medical Devices Database

The Commission of the European Union (EU) has issued its requirements for the medical...

FDA Publishes Principles for AI and ML in Medical Devices

Medical device regulatory agencies in the U.S., Canada, and the United Kingdom have recently...
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