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Comparing QSR (21 CFR Part 820) and ISO 13485 in Medical Device Manufacturing

The Quality System Regulation (QSR), established by the FDA, governs medical device manufacturers in the US, ensuring the safety and effectiveness of their products. In contrast, ISO 13485 is an international standard that provides a framework for quality management systems in the global medical device industry. Both standards emphasize quality, but QSR focuses on US regulatory compliance, whereas ISO 13485 covers broader global quality management practices.

Key Differences:

  1. Regulatory Compliance: QSR is legally binding in the US, while ISO 13485 is voluntary but recognized worldwide.
  2. Documentation Requirements: ISO 13485 mandates a quality manual, while QSR specifies detailed documentation requirements for Device Master Records, Device History Records, and Design History Files.
  3. Updates: ISO 13485 standards have undergone several updates, while the structure of QSR has remained unchanged since 1997.
  4. Design and Development: ISO 13485 emphasizes design inputs, outputs, and verification/validation activities, while QSR outlines design control requirements.
  5. Post-Market Surveillance: ISO 13485 mandates global surveillance systems, whereas QSR includes less detailed requirements.
  6. Internal Audits: Both standards require internal audits, with ISO 13485 specifying intervals.
  7. Compliance Impact: ISO 13485 enhances customer confidence, while QSR compliance is a regulatory necessity for the US market.