medical device directive Archives - In Compliance Magazine

Notified Body in Spain Illustrates MDR Compliance Complexity

The Regulatory Affairs Professional Society (RAPS) is reporting that the Spanish Notified Body (NB) is winding down it certification of medical devices for compliance with the European Union’s (EU’s) Medical De... Read More...

New Stricter EU Regulations Drafted For Medical Devices

Due to the recent Poly Implant Prothese fraud case where executives went to trial accused of supplying women with hundreds of thousands of substandard breast implants, the medical device industry agreed that an... Read More...

Software as a Medical Device – Part II

Since the 2007 amendment to the Medical Devices Directive (93/42/EC)1 aimed at clarifying its scope in relation to standalone software, there has been much debate on what types of standalone software should be ... Read More...

Software as a Medical Device – Part II

Since the 2007 amendment to the Medical Devices Directive (93/42/EC)1 aimed at clarifying its scope in relation to standalone software, there has been much debate on what types of standalone software should be ... Read More...

Updated standards list for medical devices published by EU Commission

The Commission of the European Union (EU) has issued a revised and updated list of standards that can be used to demonstrate conformity with the essential requirements its Directive 93/42/EEC concerning medical... Read More...

EU Commission revises standards list for medical device directive

The Commission of the European Union (EU) has issued a revised and updated list of standards that can be used to demonstrate conformity with the essential requirements its Directive 93/42/EEC concerning medical... Read More...

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

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

Reliant EMC is now an Authorized Distributor of AFJ Instruments Srl.

France Bans iPhone 12s for SARS Non-Compliance

2023 Ig Nobel Prizes Announced

FDA Issues Final Guidance on ISO 10993-1 for Biological Evaluation of Medical Devices

A Primer on Automotive EMC for Non-EMC Engineers

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

Energy Release Quantification for Li-Ion Battery Failures

EMC Management in Charging Applications

Common Mode Filter Design Guide

Use of Third Party EMC or Radio Test Laboratories

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

Pre-Compliance EMI Testing

(Re)Discovering the Lost Science of Near-Field Measurements, Part 2

In-Situ Radiated Emission Testing of Large Systems Installations

(Re)Discovering the Lost Science of Near-Field Measurements – Part 1

Line Impedance Stabilization is in its Seventieth Year and Still Going Strong

IEC 61249-2-43:2016, Standard for Materials for Printed Boards

ANSC C63 Committee on EMC: A 2023 Status Report

An Overview of Aerospace Battery Compliance

The Future of Wi-Fi

Military Shielding

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

Notified Body in Spain Illustrates MDR Compliance Complexity

New Stricter EU Regulations Drafted For Medical Devices

Software as a Medical Device – Part II

Software as a Medical Device – Part II

Updated standards list for medical devices published by EU Commission

EU Commission revises standards list for medical device directive

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