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requirements

FDA Exempts 70 Plus Class I Devices from 510(k) Premarket Notification

The U.S. Food and Drug Administration (FDA) has identified an extensive list of Class...

New Clinical Evaluation Requirements for Medical Devices

ANVISA, Brazil’s medical device market regulator, has announced new clinical evaluation requirements that are...

The Capacitive Discharge Test

This article will define the test requirements, and discuss the methods used to obtain results. Limitations of the equipment used will also be discussed, so that lab personnel can be made aware and do their best to minimize tolerance errors.

FDA Issues New UDI Draft Guidance

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance on...

FCC Toughens HAC Requirements

The U.S. Federal Communications Commission (FCC) has taken steps to increase consumer access to...
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New Minimum Energy Efficiency Requirements for Battery Chargers

The U.S. Department of Energy (DoE) has finalized new requirements regarding the minimum energy...

Towards a Logic-Based Extension of a Relational Software Tool for Coherent Technical Documentation of Medical Devices

This work presents a novel software tool intended to support compilation of coherent technical...

FCC Expands HAC Requirements for All Wireless Phones

The U.S. Federal Communications Commission (FCC) has expanded the scope of its hearing aid...

The Role of NEBS Requirements in the Telecom Marketplace

While product safety and reliability are core principles of virtually every manufacturer designing equipment for the telecom industry, the Telcordia Generic Requirements (GRs) that ensure the integrity of such devices and systems are not commonly understood by manufacturers around the globe.

EU sets eco-design requirements for computers

The Commission of the European Union (EU) has issued a Regulation implementing new energy...
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