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Tag: FDA inspection preparation

Quality System Regulation & QMS Compliance – XPRO AMERICA


Posted on August 22, 2025 | Posted on admin | Leave a Comment on Quality System Regulation & QMS Compliance – XPRO AMERICA

Compliance with the FDA Quality System Regulation (QSR / 21 CFR Part 820) is critical for medical device manufacturers to ensure product safety, effectiveness, and regulatory adherence. The QSR outlines…

| Tagged 21 CFR Part 820, corrective and preventive actions, device quality management, FDA audit readiness, FDA inspection preparation, FDA QMS implementation, FDA quality standards, FDA regulatory guidance, internal audits CAPA, ISO 13485 harmonization, medical device CAPA support, medical device compliance, medical device quality system, QMS documentation, QMS gap analysis, QMS record management, QSR compliance, regulatory compliance consulting, XPRO America QMS services

Medical Device Registration & Listing Compliance – XPRO AMERICA


Posted on August 22, 2025 | Posted on admin | Leave a Comment on Medical Device Registration & Listing Compliance – XPRO AMERICA

All medical device manufacturers, repackers, relabelers, specification developers, and initial importers must comply with FDA regulations for establishment registration and device listing under 21 CFR Part 807. Annual registration ensures…

| Tagged 21 CFR Part 807, annual FDA renewal, device listing compliance, device market compliance, FDA device classification, FDA device updates, fda establishment registration, FDA initial importer registration, FDA inspection preparation, FDA listing submission, FDA registration support, FDA regulatory guidance, FDA repacker compliance, foreign device manufacturer compliance, medical device audit readiness, medical device compliance consulting, medical device FDA registration, medical device regulatory strategy, XPRO America medical devices

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