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...

Decoding the Invention of the Radio

Individuals in Engineering and Technology Recognized for STEM Achievements & Community Contributions

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

Happiness barometer aims to lift spirits (from our “You Can’t Make This Stuff Up” department)

FCC Levies $6 Million Plus in Fines for Three Pirate Radio Operations

FCC Issues Proposed Rules to Prevent Digital Discrimination

FCC Launches Inquiry Into AI-Based Robocalls/Texts

De-risking Resonances in Single Conductor Structures, Such as “Ground”

ESD Co-Design for High-Speed SerDes in FinFET Technologies

GaN/SiC Transistors for Your Next Design: Fight or Flight?

Local PCB Layout Tweaks for Improved Signal Integrity When Using ESD Protection Devices

Clock Duty Cycle Tuning for Desense Mitigation in Modulation‑Involved Cases

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

Troubleshooting EMI Issues Caused by Structural Resonances

Pulse Immunity of Microprocessors/Microcontrollers

Measurement Uncertainties in Outdoor Far-Field Antenna Ranges

IT Server Hardware Compliance, Part 1

ESD Designers’ Headache with Multiple Automotive Test Requirements, Part 2

GaN/SiC Transistors for Your Next Design: Fight or Flight?

(Re)Discovering the Lost Science of Near-Field Measurements, Part 4

(Re)Discovering the Lost Science of Near-Field Measurements, Part 3

New Edition of IEC 61010-2-201:2017, Standard for Particular Requirements for Control Equipment

ANSC C63 Committee on EMC: A 2023 Status Report

An Overview of Aerospace Battery Compliance

The Future of Wi-Fi

Continuing Your Professional Education in 2020

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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