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Standards and Compliance

FDA to Host Webinar on In Vitro Diagnostic Devices EMC

The U.S. Food and Drug Administration (FDA) will host a webinar in early February...

FDA Issues Draft Guidance on Human Factors Information in Medical Device Submissions

The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to...

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...
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The 6G Future: How 6G Will Transform Our Lives

As the name suggests, 6G is the sixth generation of mobile connectivity technology. The IEEE Standards Association is building an ecosystem of interested stakeholders from across the globe to address the need for robust, responsible, and affordable wired/wireless platforms in the future.

Latest EU Ecodesign and Energy Labeling Developments

This article discusses two recent European Commission publications: a proposal for an EU Sustainable Products Regulation and the 2022-2024 Ecodesign & Energy Labelling Working Plan. Both publications raise implications for businesses involved in the manufacture and supply of electrical and electronic equipment to the EU market.

Duty to Warn Non-English Speaking and Reading Product Users

How does a manufacturer comply with its duty to warn, given the number of people in the U.S. who do not read English or any language? Does the law require multilingual labels or safety symbols, and when is it a good idea to include them?

FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help...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