In the closing months of last year, the Food and Drug Administration sent warning letters to Olympus Medical Systems Corporation and its subsidiary Aizu Olympus over violations concerning medical device reporting (MDR) requirements and quality systems regulations for endoscopes and some endoscope accessories.
FDA Issues Back-To-Back Warnings To Major Endoscope Maker Amid Device Reporting And Quality Systems Concerns
The US Food and Drug Administration issued warning letters in 2022 to Japanese device maker Olympus Medical Systems Corporation and a subsidiary concerning good manufacturing practices related to its endoscopes.
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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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