iso 13485 Archives - In Compliance Magazine

FDA to Amend Medical Device Quality System Regulation

The U.S. Food and Drug Administration (FDA) has requested public comment on its plan to harmonize its current good manufacturing practice requirements applicable to medical device quality systems with internati... Read More...

A Tsunami of Regulatory Changes is Coming

Medical device veteran Jon Speer breaks down the latest changes in the medical device regulatory landscape, both in Europe and the U.S.

New Handbook Helps Medical Devices Sector Improve its Quality Management System

ISO Publishes Revised Medical Device Quality Management Standard

After nearly four years of work, the International Organization for Standardization (ISO) has published an updated version of its standard for quality management systems used by medical device manufacturers. ... Read More...

U.S. DoE to Provide Nearly $3 Billion for EV Battery Development, Manufacturing

Wirelessly Powering IoT With 5G Network

Polymer Film Can Limit Electromagnetic Interference

Using Nanomaterials to Create a Passive Dual-Mode Heating and Cooling Device

Scientists Develop Highly Efficient Supercapacitor That Could Rival Batteries

Amateur Radio Legislation Makes Progress

Rohde & Schwarz to host RF Design Challenge at IMS2023

New Waveguide Power Amps Support Frequency Bands from 26.5 to 96 GHz

SIGLENT TECHNOLOGIES Introduces Handheld Spectrum and Vector Network Analyzer

Hot Stuff (and Warnings)

ESD Designers’ Headache with Multiple Automotive Test Requirements, Part I

Troubleshooting EMI Issues Caused by Structural Resonances

Energy Release Quantification for Li-Ion Battery Failures

EMC Management in Charging Applications

Common Mode Filter Design Guide

SCIF and Radio Frequency Secured Facility Design, Part 2

FCC Expands Role of TCBs in Equipment Authorization Regime

Seventy Years of Electromagnetic Interference Control in Planes, Trains, and Automobiles (and Ships and Spaceships, as well)

ESD Designers’ Headache with Multiple Automotive Test Requirements, Part I

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

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

9 Steps to Select a Test Cable for Millimeter Wave Applications

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

Newly Released IEC 62586 Part 2 for Power Quality Parameters in Power Supply Systems

The Future of Wi-Fi

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

China’s Latest Regulation on 2.4 GHz and 5 GHz Equipment

Characteristics of Air as an Insulator

NASA Space Shuttle’s Return to Flight: The Untold Electromagnetic Backstory

Continuing Your Professional Education in 2022

A Recipe for Success: How to Grow from EMC Novice to EMC Expert

Capacitors: Theory and Application

Ohm’s Law Also Applies to ESD‑Induced Heat Pulses

RF Tech Tip: BNC Versus Threaded Connectors

FDA to Amend Medical Device Quality System Regulation

A Tsunami of Regulatory Changes is Coming

New Handbook Helps Medical Devices Sector Improve its Quality Management System

ISO Publishes Revised Medical Device Quality Management Standard

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