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- This is a quality system regulation, not a voluntary standard
- The QSR is generic in nature due to the fact that there are more than 12k devices in the marketplace
- Management is held accountable for the quality management system
- The QSR is applicable to organizations who sell a medical device in the US, regardless of their geographic location
- Not all requirements are applicable to low-risk devices (class 1)
- The QSR Regulation addresses the following areas:
- design controls
- material controls
- corrective and preventive actions
- production and process controls
- equipment and facility controls
- document and record controls
- FDA can take enforcement action for non-compliance with the QSR
- Specific requirements for device labeling, complaint handling and recalls appear in other regulations.
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