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Top 10 Barriers Manufacturers Face with Medical Standards

2 months ago

Medical electrical equipment standards are complex—and noncompliance is costly. This article breaks down the top 10 barriers manufacturers face when navigating IEC 60601 and related standards, from EMC testing and isolation diagrams to risk management and software documentation, with practical guidance to streamline certification and avoid delays.

The post Top 10 Barriers Manufacturers Face with Medical Standards appeared first on In Compliance Magazine.

Elizabeth Casey

The IEC 60601 Family of Standards and the 4th Edition of IEC 60601‑1

2 months ago

The IEC 60601 family of standards is undergoing its most significant update in decades. This article explains how the 4th Edition of IEC 60601‑1 restructures safety, performance, terminology, and collateral requirements—and what these changes mean for medical electrical equipment development, conformity assessment, and future regulatory pathways.

The post The IEC 60601 Family of Standards and the 4th Edition of IEC 60601‑1 appeared first on In Compliance Magazine.

Brodie Pedersen

Documents Can Be Your Friend or Foe

2 months ago

Product documentation can protect manufacturers—or expose them to serious liability. This article explains best practices for managing product safety records across the product lifecycle, including defensive writing, document retention, post‑sale reporting, and structured document management programs that demonstrate proactive commitment to safety, regulatory compliance, and product liability risk reduction.

The post Documents Can Be Your Friend or Foe appeared first on In Compliance Magazine.

Kenneth Ross

Impact of PCB Via and Trace Geometry on the Effectiveness of Decoupling Capacitors, Part 2

2 months ago

Conducted emissions testing on custom PCBs shows how moving a decoupling capacitor farther from an IC can increase emissions across multiple frequency bands. Using CISPR 25 methods, this study compares capacitor placements and via topologies to reveal how distance and inductance shape PDN behavior.

The post Impact of PCB Via and Trace Geometry on the Effectiveness of Decoupling Capacitors, Part 2 appeared first on In Compliance Magazine.

Bogdan Adamczyk

Small Form Factor CDM Testing, Part 3

2 months ago

Small form factor devices often fail traditional field‑induced CDM testing, prompting the need for contact‑first methods. This article compares CC‑TLP, low‑impedance contact CDM, and relay‑based CDM techniques, outlining how each provides more repeatable, lower‑noise stress conditions for bare die and wafer‑level testing.

The post Small Form Factor CDM Testing, Part 3 appeared first on In Compliance Magazine.

Kathleen Muhonen

Automation-Ready Electrical Safety Testing For Smart Manufacturing

2 months ago

Learn how electrical safety testing must adapt to Industry 4.0 production environments with automated, high-speed hipot testing. This application note explains how programmable tests, seamless PLC/robot integration, and traceable data capture with Vitrek testers help manufacturers boost throughput, improve quality, and maintain compliance in smart, automated production lines.

The post Automation-Ready Electrical Safety Testing For Smart Manufacturing appeared first on In Compliance Magazine.

Vitrek

Würth Elektronik Presents a Differential Pressure Sensor

2 months ago

The WSEN‑PDMS is a highly accurate differential pressure sensor offering ±1 mbar precision, 16‑bit resolution, and flexible analog or digital interfaces. With multiple nozzle options, broad MCU compatibility, and a –25°C to +85°C operating range, it supports HVAC, filtration, automation, and medical applications.

The post Würth Elektronik Presents a Differential Pressure Sensor appeared first on In Compliance Magazine.

Wurth Elektronik