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Standards by Topic

China’s Latest Regulation on 2.4 GHz and 5 GHz Equipment

This article addresses China’s latest requirements, including technical details, for 2.4 GHz and 5 GHz equipment.

South Korea KS C 9814-1:2022 Standard

This article addresses the latest changes to the KS C 9814-1 (and CISPR 14-1) standard.

FBI Recommends Actions to Protect Medical Devices from Cyberattacks

The U.S. Federal Bureau of Investigation (FBI) has issued a report detailing the potential...

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help...

FDA Underfunding May Be Impacting Medical Device Cybersecurity Protections

Insufficient funding and a lack of trained personnel at the U.S. Food and Drug...
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ESD Compliance in a Server Room

A careful review of empirical research, multiple ESD standards, and return on investment provides a strong case for evaluating the installation of ESD flooring in server rooms and data centers.

FDA Updates Recognized Standards List

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

FDA Launches New Premarket Submissions Tracker

The U.S. Food and Drug Administration (FDA) has now made available an online platform...

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...
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