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  "documentTitle": "iRhythm Technologies, Inc. (IRTC)",
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      "text": "Regulatory Compliance Consultant Answers to the Question: \"Was iRhythm's Contention That the Results Analysis Activity is NOT Part of Its Product a Credible Position or Should They Have Known Better?\"",
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      "text": "We spoke with two medical device regulatory compliance consultants, both of whom believed that, in their opinion, iRhythm’s failure to report complaints was indefensible.",
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      "text": "We spoke with two medical device regulatory compliance consultants, both of whom believed that, in their opinion, iRhythm's failure to report complaints was indefensible. We believe capturing, tracking, and analyzing complaints to inform assessments of product safety are one of the most fundamental quality control activities of any medical device company.",
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      "text": "They should have known better. I don't know if it fringes on gross negligence, but I still see it to this day...it's still your responsibility. So, they should have known better. And that takes me back to who's running the shop and what's their background, how do they not know, why are they thinking this? There's always a why; sometimes you might never know what that why is, but something's off. — Spruce Point Interview with Medical Device Regulatory Consultant, June 2025",
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      "text": "Tegus Interview with Regulatory Consultant, 2/25/25: \"Now, the fact that companies don't review complaints for MDRs is sloppiness...\"",
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