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FDA QMS Requirements
 
You will need to establish and maintain a Medical Quality Management System, compliant with the cGMP/QSR requirements, as described in 21 CFR Part 820.
The FDA will perform the QSR inspection within 2 years of 510(k) approval of the device.
The QSR requirements include the following general issues:
  1. Quality manual

  2. General standard operating procedures for managing a manufacturing plant. For example:
    • Complaint handling procedure
    • Quality control procedure
    • Incoming components / raw materials inspection procedure
    • Quality system audit procedure


  3. Device specific standard operating procedures for manufacturing the device. For example:
    • Device and component specifications
    • Assembly procedure
    • Device and component testing procedures
    • Process validation
    • Device Master Record
    • Device History Record


  4. Documentation for recording all events required by the standard operating procedures.

  5. Documentation of Design Control Activities.
 
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