leo eisner Archives - In Compliance Magazine

The Future of the IEC 60601 Series: An Update

This article discusses where we are currently with the IEC 60601 series of standards and where we are headed for the next round of amendments (2020 - 2022). Further down the line is the development of the next full edition of the IEC 60601 Series (targeting around 2024 publication).

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World

This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.

Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.

Home Use Medical and Wellness Devices

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

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

Engineers Produce Electricity from Jet Fuel Without High Heat

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

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

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

Troubleshooting EMI Issues Caused by Structural Resonances

Energy Release Quantification for Li-Ion Battery Failures

Electrical Safety Tester Verification

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

IEC PAS 63077:2016 Released for Restoring Medical Imaging Equipment

ANSC C63 Committee on EMC: A 2023 Status Report

An Overview of Aerospace Battery Compliance

The Future of Wi-Fi

Engineering Our Future: A View of Changes Facing Engineers

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

The Future of the IEC 60601 Series: An Update

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World

Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents

Home Use Medical and Wellness Devices

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