The Complaint Nobody Called a Complaint: Why Medical Device Companies Miss Early Warning Signals
The Complaint Nobody Called a Complaint: Why Medical Device Companies Miss Early Warning Signals Most complaint-handling failures do not begin when an investigation is missed. Instead, they start earlier, at the moment when no one realizes they are looking at a potential complaint. For example, a customer mentions an unusual product issue during a support […]
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Key Regulatory References for the FDA Medical Device Inspection Compliance Program
Key Regulatory References for the FDA Medical Device Inspection Compliance Program IntroductionFDA has released the Inspection of Medical Device Manufacturers Compliance Program 7382.850, effective February 2, 2026, formally replacing the long-standing Quality System Inspection Technique (QSIT). That alone is a big deal. Combined with the rollout of the Quality Management System Regulation (QMSR), it signals […]
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Less Than A Year to Go! FDA New Quality Management System Regulation (QMSR) Is Getting Closer
Less Than A Year! FDA’s QMSR Is Getting Closer The new Quality Management System Regulation (QMSR) ├óΓé¼ΓÇ£ FDA├óΓé¼Γäós long-awaited update to the medical device quality system requirements in 21 CFR Part 820 ├óΓé¼ΓÇ£ is just one year away from becoming effective. The two-year transition period ends on February 2, 2026, when the Agency will begin […]
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FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know
It’s Here! FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know For years, US FDA has been talking about aligning the existing FDA Quality System Regulation (QSR) with ISO 13485. FDA has finally pushed the updated 21 CFR Part 820 across the finish line with the publication of the new Quality Management System […]
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ISO 13485:2016 and ISO 9001:2015: Are They Aligned?
FDA QSR vs. QMSR: What Medical Device Manufacturers That DO NOT Have ISO 13485 Need to Know Short answer:├é┬áNo. Longer answer:├é┬áFrom a high-level perspective, the standards now differ in intent, content, and structure. ├é┬á A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016 ├é┬á Intent:├é┬áNot fully aligned The standards share one ultimate […]
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Medical Device QMS 101: What It Is, Where It’s Required, and Key Regulations to Know
Medical Device QMS 101: What It Is, Where It├óΓé¼Γäós Required, and Key Regulations to Know In this article: Regulations Governing a Medical Device QMSRelationship Between Medical Device Approval and Your QMSKey Components of a Quality Management System that Meets US FDA and EU RequirementsDeveloping a Medical Device QMSUnderstanding Key Obligations in ISO 13485:2016 and the […]
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