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For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the long-standing quality system regulation (QSR) and quality system inspection technique (QSIT) models…
ISO has set its focus on revising three key management system standards this year. It started with ISO 14001, which covers environmental management and was published on April 15, 2026. ISO 9001 for quality management will follow in the fall. For ISO 45001, the occupational health and safety standard, only an initial draft is expected in 2026; the final version isn’t due until 2027.
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With Hexagon Manufacturing Intelligence’s recent announcement of its inclusion in the NASCAR Competition Partner Program, details on the strategic partnership have emerged. By cementing this tie, the two companies can expand a professional relationship that will enable them to focus on precision, quality control, standards, reliability, and performance.
Like any other industry,…
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