Final answer:
Document Controls as outlined in the QSR apply to the Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR), encompassing all elements of the medical device recordkeeping requirements to ensure regulatory compliance.
Step-by-step explanation:
According to the Quality System Regulation (QSR) for medical devices, Document Controls apply to:
- Design History File (DHF)
- Device Master Record (DMR)
- Device History Record (DHR)
- All of the above
Document Controls are a critical part of the QSR, ensuring that documents (approvals, changes, etc.) are properly maintained for these elements of the medical device recordkeeping requirements. The DHF contains the records of a medical device's design history, the DMR includes the specifications and production protocols, and the DHR is a compilation of records pertaining to the production of a device. Managing these documents is essential for compliance with regulatory standards and for the effective and safe manufacture of medical devices.