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Standards and Compliance

FDA Launches Medical Device Radiation Sterilization Master File Pilot

The U.S. Food and Drug Administration (FDA) has announced the creation of a new...

EU Commission Updates MDR/IVDR Transitional Provisions

The Commission of the European Union (EU) has modified the transitional provisions of its...

FDA Posts Updated FAQs on Medical Device Cybersecurity

The U.S. Food and Drug Administration (FDA) has released an updated list of frequently...

Top 10 ISO/IEC 17025:2017 Deficiencies Found in Electronics Testing Laboratories

Whether your organization is seeking ISO/IEC 17025 accreditation for the first time or renewing a current accreditation, there are a few frequently overlooked or misunderstood sections of the standard to pay attention to.

Automotive EMC Testing: CISPR 25, ISO 11452-2 and Equivalent Standards, Part 2

This two-part article provides an overview of current automotive EMC standards and the intricacies of chamber testing automotive systems and components.
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IEEE Recommended Practice for Antenna Measurements

Even if you are not involved in the practice of the measurement of antennas but have a passing interest and would like to learn more, this is the standard to read. Doing so will quickly get you up to speed, saving you many hours of unnecessary research and much confusion.

NIST Releases AI Risk Management Framework

As artificial intelligence (AI)-based technology and systems are more widely deployed, the U.S. National...

FDA Releases Third-Party Review Performance Report

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

EU Commission Proposes to Extend MDR/IVDR Deadlines

The Commission of the European Union (EU) has proposed extending the transition period for...

Automotive EMC Testing: CISPR 25, ISO 11452-2 and Equivalent Standards, Part 1

This two-part article provides an overview of current automotive EMC standards and the intricacies of chamber testing automotive systems and components.
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