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...

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

Material Found to Block Electromagnetic Waves

Mobility Fund Phase 1 Auction

FCC Initiates Auction for 5G Mid-Band Spectrum

FCC Warns of Rising Threat of Scam Robotexts

FCC Fines Electronics Marketer for Selling Non-Compliant Wireless Devices

Novel Approaches for the Detection of Counterfeit Electronic Components

Common Mode Filter Design Guide

SCIF and Radio Frequency Secured Facility Design, Part 2

Using Multiport Connectors in High-Frequency Military and Avionics Systems

Low-Frequency Magnetic Fields in Electric Vehicles

Incorporating Ethical Considerations into the Design Process

Conducted Emissions Feedback from VSD-Operated Products

Everything You Need to Know About EV Battery and BMS Testing in Validation and Production Scenarios

Reducing Battery Life Risk in Mission Critical IoT Devices

A Bias Tee for Broadband Measurement of Power Electronic Components

Continuity and Change in International Wireless Approvals

Users Guide to Hipot Testing

Evolution and Analysis of EMC Specifications at a Major Automotive OEM

Conducted Emissions Feedback from VSD-Operated Products

Revisions to IEC 61800-5-2, Standard for Power Drive Systems

The Rise of Time-Sensitive Networking (TSN) in Automobiles, Industrial Automation, and Aviation

Expected Service Life of Medical Electrical Equipment

Toward Standardization of Low Impedance Contact CDM

Advances in Data Transmission Speeds for RJ45 Jack Connectors

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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