In Compliance Magazine

A2LA VP Trace McInturff Elected First Chair of the Global Accreditation Cooperation Incorporation

1 month 4 weeks ago

A2LA's Trace McInturff makes history as first Chair of Global Accreditation Cooperation's Arrangement Management Committee. The newly formed organization unifies IAF and ILAC, creating a clearer path for international laboratory and certification body recognition.

The post A2LA VP Trace McInturff Elected First Chair of the Global Accreditation Cooperation Incorporation appeared first on In Compliance Magazine.

In Compliance

Report Says Insufficient FDA Staffing Limits Oversight of Med Device Recalls

2 months ago

The FDA's medical device recall oversight is failing—and staffing shortages are to blame. GAO's December report shows nearly three-quarters of recalls exceeded termination targets during 2020-2024, with congressional recommendations for strategic staffing increases now on the table.

The post Report Says Insufficient FDA Staffing Limits Oversight of Med Device Recalls appeared first on In Compliance Magazine.

In Compliance

The EMC Demo Box

2 months 1 week ago

Teaching EMC doesn't require expensive labs. The EMC Demo Box brings electromagnetic compatibility to life in any classroom, demonstrating real coupling, radiation, and shielding effects through hands-on measurements that transform theory into lasting understanding.

The post The EMC Demo Box appeared first on In Compliance Magazine.

Marcel van Doorn

ISO 17025 Accreditation from a Test Lab’s Perspective

2 months 1 week ago

Third-party test labs undergo rigorous ISO 17025 accreditation audits lasting days or weeks. Learn what auditors scrutinize—from equipment calibration to facility layouts—and why accredited labs provide manufacturers with the highest-quality compliance testing and reliable results.

The post ISO 17025 Accreditation from a Test Lab’s Perspective appeared first on In Compliance Magazine.

Marilyn Sweeney

Mastering High Voltage: The Importance of Accurate Test Equipment

2 months 1 week ago

This whitepaper underscores that precise calibration of high-voltage test gear — especially when measuring 1 kV–150 kV systems — is essential for safety, reliability, and regulatory compliance. It details measurement techniques (voltage dividers, step-down transformers, etc.), the impact of environmental and connection factors on accuracy, and why traceable calibration (e.g. to NIST / A2LA) is a must to ensure consistent, reliable results.

The post Mastering High Voltage: The Importance of Accurate Test Equipment appeared first on In Compliance Magazine.

Vitrek

FDA Updates Lists of AI and Digital Health Medical Devices

2 months 3 weeks ago

The FDA has updated its lists of medical devices with digital health technologies, including AI-enabled devices, AR/VR medical devices, and sensor-based digital health technology. These FDA-authorized device lists help healthcare providers understand the current digital health landscape and support informed use of advanced medical technologies in patient care.

The post FDA Updates Lists of AI and Digital Health Medical Devices appeared first on In Compliance Magazine.

In Compliance

AHA Recommends AI Medical Device Safeguards to FDA

2 months 3 weeks ago

The American Hospital Association is urging the FDA to establish regulatory standards for AI-enabled medical devices. The AHA recommends an AI policy framework balancing healthcare innovation with patient privacy protection. AI medical devices have grown significantly in healthcare settings, particularly in diagnostic imaging and radiology applications.

The post AHA Recommends AI Medical Device Safeguards to FDA appeared first on In Compliance Magazine.

In Compliance

Design Considerations for EMC Test Chambers

3 months ago

Planning an EMC test chamber? Electromagnetic compatibility (EMC) test chambers are specialized facilities for evaluating electronic devices against electromagnetic interference. This guide explores essential design considerations—including RF absorber selection, shielding materials, and chamber configuration—to help engineers create accurate, compliant testing environments that meet industry standards.

The post Design Considerations for EMC Test Chambers appeared first on In Compliance Magazine.

Don MacArthur

EMC Compliance in Wireless Devices

3 months 1 week ago

Wireless devices face a perfect storm of EMC challenges—high frequencies, cramped circuits, multiple antennas battling for space, and noisy urban environments. Discover how industry giants like Apple, Fitbit, and Tesla engineer their way around electromagnetic chaos through ingenious shielding, filtering, and design tricks that keep your gadgets running flawlessly.

The post EMC Compliance in Wireless Devices appeared first on In Compliance Magazine.

Don MacArthur
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4 minutes 47 seconds ago
In Compliance Magazine
Electronic Design, Testing, and Compliance
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