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Standards and Compliance

FBI Recommends Actions to Protect Medical Devices from Cyberattacks

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

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FDA Releases Draft Guidance on Production and Quality System Software

The U.S. Food and Drug Administration (FDA) has released draft guidance intended to help...
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FDA Underfunding May Be Impacting Medical Device Cybersecurity Protections

Insufficient funding and a lack of trained personnel at the U.S. Food and Drug...

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...
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