In Compliance Magazine

FDA Finalizes Guidance on Weight-Loss Devices

1 month 3 weeks ago

The FDA has finalized guidance on premarket submission requirements for weight loss medical devices, covering non-clinical testing, clinical study design, and benefit-risk analysis. Developers of intragastric implants, aspiration therapy systems, and neuromodulators will want to review the agency's recommendations closely.

The post FDA Finalizes Guidance on Weight-Loss Devices appeared first on In Compliance Magazine.

In Compliance

Navigating Accreditation: Why Testing Laboratories Need to Meet Global Standards

2 months ago

Global markets don’t run on assumptions—they run on accredited data. ISO/IEC 17025 laboratory accreditation gives manufacturers the consistency, accuracy, and credibility regulators expect. See why accreditation has become a competitive advantage across every major industry.

The post Navigating Accreditation: Why Testing Laboratories Need to Meet Global Standards appeared first on In Compliance Magazine.

Don MacArthur

FCC Finalizes Measures to Advance Broadband Rollout

2 months ago

The FCC has adopted new rules to accelerate high‑speed network deployment, eliminating certain filing requirements and streamlining technology transition processes. The changes also grant blanket authority to grandfather legacy services, freeing resources to expand modern broadband infrastructure and transition communities away from outdated copper networks.

The post FCC Finalizes Measures to Advance Broadband Rollout appeared first on In Compliance Magazine.

In Compliance

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

ITG Electronics Launches Ultra-Low-Profile 5mm Dual-Channel Power Block Delivering 80A per Phase

2 months 1 week ago

ITG’s PM1201C081 Series is an ultra‑low‑profile 5mm dual‑channel power block delivering 80A per phase with a 37.5% boost in power density. Its compact footprint, strong thermal performance, and integrated protection features make it ideal for high‑density data center, telecom, and networking applications.

The post ITG Electronics Launches Ultra-Low-Profile 5mm Dual-Channel Power Block Delivering 80A per Phase appeared first on In Compliance Magazine.

ITG Electronics

Troubleshooting EFT, Part 1

2 months 1 week ago

Electrically fast transient (EFT/B) testing simulates switching and motor-induced transients that can disrupt electronic systems. This article explains the fundamentals of EFT immunity, outlines practical benchtop testing alternatives, and provides step-by-step guidance for identifying and resolving EFT susceptibility before formal compliance testing.

The post Troubleshooting EFT, Part 1 appeared first on In Compliance Magazine.

Kenneth Wyatt

OPEX Completes CRA Readiness Assessment with ONEKEY

2 months 2 weeks ago

OPEX Corporation has completed a Cyber Resilience Act (CRA) Readiness Assessment with ONEKEY as part of its CRA Fast Start program. The assessment validated OPEX’s secure development practices and identified targeted improvements to support upcoming EU cybersecurity compliance requirements.

The post OPEX Completes CRA Readiness Assessment with ONEKEY appeared first on In Compliance Magazine.

OPEX Corporation

ETSI Releases OpenOP v1 to Support Telco Cloud Federation and 6G Experimentation

2 months 2 weeks ago

ETSI has released the first version of OpenOP, an open-source operator platform enabling telco cloud network federation and 6G experimentation. OpenOP Release 1 supports CAMARA APIs, edge cloud orchestration, and AI-driven capability exposure for developers, operators, and research communities.

The post ETSI Releases OpenOP v1 to Support Telco Cloud Federation and 6G Experimentation appeared first on In Compliance Magazine.

ETSI

Common Compliance Pitfalls: Lessons Learned from Real-World Case Studies

2 months 2 weeks ago

Compliance failures can devastate product development—leading to recalls, financial losses, and long-term brand damage. This article explores real-world engineering case studies, including Samsung’s battery recall, Volkswagen’s emissions scandal, Intel’s processor bug, and Boeing’s 737 MAX issues, revealing actionable lessons to strengthen compliance, safety, and quality processes across industries.

The post Common Compliance Pitfalls: Lessons Learned from Real-World Case Studies appeared first on In Compliance Magazine.

Don MacArthur

FCC To Accelerate Access to High-Speed Networks

2 months 2 weeks ago

The Federal Communications Commission plans to vote on new rules designed to speed deployment of high‑speed networks. The proposal would remove certain filing requirements, streamline technology transition approvals, and allow carriers to retire legacy copper-based services in favor of next-generation infrastructure.

The post FCC To Accelerate Access to High-Speed Networks appeared first on In Compliance Magazine.

In Compliance

FDA Publishes Updated Guidance on Cybersecurity Premarket Submissions

2 months 2 weeks ago

The U.S. Food and Drug Administration has issued updated guidance on cybersecurity requirements for medical device premarket submissions, aligning more closely with current quality management system standards, emphasizing lifecycle risk management, and encouraging manufacturers to adopt secure product development frameworks.

The post FDA Publishes Updated Guidance on Cybersecurity Premarket Submissions appeared first on In Compliance Magazine.

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