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?

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

Turning Snowfall Into Electricity

FCC Adopts Rules on Scam Texting

FCC Proposes $2.3 Million Fine for Pirate Radio Broadcasting

FCC Updates References to Equipment Authorization Standards

It’s Not a Bunch of Labels – It’s a System

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

Using Multiport Connectors in High-Frequency Military and Avionics Systems

Maximum Received Power Statistics within RF Reflective Enclosures for HERO/EMV Testing

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

Evaluation of Intelligent and Non‑Static Power Sources: A Rational Clarification

Why Histograms and Free Run Matter

Performing Proximity Magnetic Fields Immunity Testing

High Voltage ESD Protection for Automotive Ethernet Applications

Tailoring Safety Into Audio Frequency Power-Line Susceptibility Testing

IEC Published New Edition of IEC 61000-4-19

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

South Korea KS C 9814-1:2022 Standard

The 6G Future: How 6G Will Transform Our Lives

Let's Talk About... The Importance of Reading

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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