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Tag: medical device compliance

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

De Novo Device Classification & FDA Support – XPRO AMERICA


Posted on August 22, 2025 | Posted on admin | Leave a Comment on De Novo Device Classification & FDA Support – XPRO AMERICA

The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain…

| Tagged De Novo FDA submission, FDA clearance strategy, FDA compliance support, FDA device classification, fda establishment registration, FDA labeling review, FDA market entry, FDA performance testing, FDA post-market guidance, FDA regulatory consulting, FDA regulatory strategy, FDA reviewer liaison, FDA risk analysis, FDA submission support, FDA technical file review, medical device compliance, medical device FDA approval, novel device clearance, XPRO America De Novo services

Recent Posts

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  • Quality System Regulation & QMS Compliance – XPRO AMERICA
  • Premarket Approval (PMA) Applications for Class III Devices – XPRO AMERICA

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