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Standards and Compliance

FDA Releases Guidance on UDI Systems for Medical Devices

The U.S. Food and Drug Administration (FDA) has published a Final Guidance on the...

FDA Issues Guidance on Remanufacturing of Medical Devices

The U.S. Food and Drug Administration (FDA) has released a draft guidance detailing the...

The American National Standards Committee on EMC – C63®

This article describes the activities of the C63 Committee on EMC over the last two years. It summarizes how the Committee has been remotely meeting and reports on the progress the Committee has made on its active EMC standards.

Exporting Radio Equipment to Saudi Arabia: A Look at the Law

This article discusses the legislation that applies when placing radio equipment on the Saudi market. For product manufacturers intent on exporting radio equipment to Saudi Arabia, the fact that the relevant legislation was adopted at the national level is significant. The article gives an overview of the Saudi legal framework, including obligations falling upon radio equipment manufacturers and importers.

The EU’s MDR is Now in Effect

The European Union’s (EU’s) new regulation for medical devices sold or imported into the...
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FDA Releases 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

Protection of High Voltage Power Substation Control Electronics from HEMP and IEMI

This article discusses techniques for assessing the effectiveness of existing shielding and penetration protection in power substations against early-time, high-altitude electromagnetic pulse (E1 HEMP) and intentional electromagnetic interference (IEMI).

Lightning and RF Electrical Bonding

Everything you need to know about the lightning and radio frequency bonding requirements in military and aerospace standards (and nothing you don’t!)

SCIF and Radio Frequency Secured Facility Design

Secure facility designs often comingle ICS/ICD-705 and NSA 94-106 design requirements, creating project confusion with significant design and cost implications. This article focuses on bringing some clarity to the differences between ICS/ICD-705 design guidance and NSA 94-106 performance requirements. The related secure facility design and construction process is also reviewed.

FDA Warns of Potential Effects of Magnets in Cell Phones and Smartwatches

The U.S. Food and Drug Administration (FDA) is advising consumers with embedded pacemakers and...
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