August 2016

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Standards and Compliance

Home Use Medical and Wellness Devices

Why are home use medical and wellness devices drawing so much attention and growing at an explosive rate?

Industry

U.S. Marketing Authorization of Novel Medical Devices

Common FDA Regulatory Pathways for Uncommon Devices

Design

Digital Hearing Aids: Designing for EMC Compliance

To protect the hearing health of hearing aid users, researchers in the relevant areas have been studying the effects of EMI on hearing aids.

Testing

Top 10 A2LA Deficiencies Cited During Assessments in the Electrical Field

Quite often, we are asked about the most common deficiencies that are cited by assessors during A2LA assessments to ISO/IEC 17025:2005.

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Columns

Something Funny Happened on the Way to an MRA

Even in the arcane world of Conformity Assessment, surprises are afoot.

Columns

Leakage Current Measuring Circuits

The leakage current measuring circuits in IEC 950 and those in North America are exactly the same.

Columns

Orientation Is Relevant For EMI/EMC Filters

When designing an EMI/EMC filter the orientation relative to source and victim is critical for high effectiveness. Can you save components in your filters?

August 2016

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What's New

New Würth Elektronik Reference Guide “ABC of Shielding”

FCC Enforcement Bureau Convenes Regulators to Discuss Emerging Trends

ARRL Releases Updated Amateur Radio Handbook

EMC Bench Notes: Pre-Compliance Testing for Radiated Emissions, Part 4 – Measurement Software

FDA Classifies Radiofrequency Toothbrush as Medical Device