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MDSAP Extends Remote Auditing Option

The International Medical Device Regulators Forum (IMDRF) has temporarily extended the limited use of...

EU Commission Sets Criteria for Reference Labs under the IVDR

The Commission of the European Union (EU) has recently detailed the criteria and tasks...

The Rise of Time-Sensitive Networking (TSN) in Automobiles, Industrial Automation, and Aviation

Speed and determinism in design, made possible by time-sensitive networking (TSN) technology, is prompting the development of new TSN profiles for a multitude of applications across industry sectors. The IEEE 802.1™ Working Group of the IEEE Standards Association (IEEE SA) offers numerous TSN profiles for applications, including the automotive, manufacturing, and aviation industries.

FDA Issues Updated EMC Guidance for Medical Devices

The U.S. Food and Drug Administration (FDA) has finalized its guidance on electromagnetic compatibility...

EU Commission Updates Harmonized Standards for Quality Management in Medical Devices

The Commission of the European Union (EU) has updated its list of harmonized standards...
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FDA Updates List of Recognized Standards

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

FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain...

FDA Updates Data on Breakthrough Device Program

The U.S. Food and Drug Administration (FDA) reports that it has granted more than...

Senate Introduces Medical Device Security Act

The U.S. Senate has introduced a bipartisan measure that would help to ensure the...

FDA Clarifies Cybersecurity Recommendations for Medical Devices

The U.S. Food and Drug Administration (FDA) has issued an updated draft guidance that...
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