EMC Bench Notes

EMC Bench Notes: Interpreting Emissions Using a Near-Field Probe

Not all EMC emissions look alike — and knowing the difference can save your compliance test. Kenneth Wyatt breaks down how to use near-field probes to identify and interpret broadband versus narrowband emission profiles, so you can trace noise back to its source before it becomes a costly failure.

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U.S. Food and Drug Administration (FDA)

FDA Releases Guidance Document on Human Factors Information in Marketing Submissions

The FDA has finalized its guidance on human factors information required in medical device marketing submissions, outlining a risk-based framework for 510(k)s, PMAs, De Novo requests, and HDE applications. Here's what manufacturers need to know before their next premarket submission.
U.S. Food and Drug Administration (FDA)

FDA Updates List of Recognized Consensus Standards

The FDA has updated its list of more than 1,700 recognized voluntary consensus standards used to demonstrate compliance in medical device premarket submissions. Find out which specialties are covered and how declarations of conformity can streamline your path to market authorization.
U.S. Federal Communications Commission (FCC)

FCC Approves New Source for Verifying E911 Location Accuracy

The FCC has approved T-Mobile's request to incorporate data from the EU's Galileo satellite navigation system into its E911 emergency location services — a move the Commission says will improve emergency response and save lives without increasing device interference risks.

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Compliance Resources

White Papers

Demystifying IEC 60601: A Practical Guide For Understanding The Standards

This whitepaper demystifies the IEC 60601 family of medical electrical safety standards, explaining general, collateral, and particular requirements and how they impact global market access. It offers practical guidance on integrating compliance, risk management, and testing strategies early to streamline regulatory approval and accelerate time to market.

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European Union

EU Commission Issues Draft Guidelines for AI Systems

The EU Commission is seeking public comment on draft guidelines designed to help providers and deployers determine whether their AI system qualifies as high-risk under the AI Act — with the comment period open through June 23, 2026.
Standards and Regulations

MIL-STD-461H: A Review

MIL-STD-461H dropped in April 2026 with no new requirements and no new test equipment — so what changed? Ken Javor breaks down every substantive update, and why most of them exist to stop EMC lawyers from gaming the standard.

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Feature Articles

Standards and Compliance

Global Market Access for Bluetooth Devices

Getting a Bluetooth device to market in one country is a project — getting it to market in 30 is a whole other challenge. Grace Lin maps the regulatory landscape across major economies, from FCC certification to RF exposure rules and labeling requirements worldwide.
Design

Host Integration of Pre-Certified Radio Modules

Dropping a pre-certified radio module into your product sounds like a compliance shortcut — but integration choices can still land you back at the test lab. Cory Bradshaw and Craig Brandt explain what manufacturers need to get right before and after the module goes in.

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