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Beyond the Statistics: Implementing the New <em>VDA AIAG SPC Manual</em>

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With the publication of the new VDA AIAG SPC Manual in July 2026, one of the most significant changes to statistical process control (SPC) in decades has been introduced.

Regulatory Harmonization: IMDRF, GHWP, and the Road Ahead

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Medical device companies selling into multiple countries don’t answer to one global regulator. They navigate a patchwork of national requirements that two organizations are trying to align in very different ways. 

Five Global Product Compliance Trends Every Manufacturer Should Prepare For

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Product compliance is moving beyond certificates and restricted-substance checks.

The Strategic Role of Electrotechnologies

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In the electrotechnology sector, we know one thing for certain: Trust can’t be imposed; it must be built. Standardization enables us to build it every day.

Protecting Food Quality in the Wake of the Cyclosporiasis Outbreak

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The recent multistate outbreak of cyclosporiasis is a powerful reminder that food quality involves more than appearance, consistency, and shelf life.

How Connected Software Strengthens Food Safety Compliance and Mitigates Risk

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Quality teams throughout the food manufacturing industry face increasingly difficult obstacles and risks while keeping our food safe.

Demonstrating Process Effectiveness: Preparing Your QMS for ISO 9001:2026

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As this article is being written, the (final draft) FDIS ISO 9001:2026 global vote has concluded, and we should soon see the new published requirements.

AI’s Role in Strengthening the Future Workforce for Healthcare Technology Management

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The healthcare technology management (HTM) industry is facing a looming labor shortage and must attract enough skilled professionals to meet future demand.

ISO 9001 Sets New Rules of Play for Quality Management

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The complexity of today’s manufacturing operations and ever-evolving digital disruptions, including the biggest of all, artificial intelligence (AI), require standards that set the pace and keep organizations around the world aligned with what quality looks like. 

How Experts Use Decades of Knowledge: Content, Context, Consequence

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Speaking with experts who love their jobs usually makes you aware of two things simultaneously: 1) how much you don’t know, and 2) how much you’d like to know. My conversations with Prashant Darisi and Vick Vaishnavi were no exception.

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