Med Device & Packaging

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Across
  1. 2. Testing required to ensure packaging can withstand transportation
  2. 3. Controlled facility conditions required for packaging operations
  3. 8. Type of medical device file required by ISO 13485
  4. 10. Documented plan for testing and validation of packaging systems
  5. 13. Key ISO 13485 clause covering supplier and outsourced process control
  6. 14. Records must be maintained to demonstrate this regulatory requirement
  7. 15. Documented plan for testing and validation of packaging systems
  8. 17. International standard for medical device quality management system
  9. 18. Document detailing materials and methods and criteria used for a package
Down
  1. 1. A system that prevents ingress of microorganisms and maintains sterility
  2. 4. Action taken to eliminate the cause of a detected nonconformity
  3. 5. A documented system to show how requirements are met in a QMS
  4. 6. Seal that must remain intact until the point of use
  5. 7. Risk-based approach required throughout the product lifecycle
  6. 9. Documented evidence that a process consistently produces results
  7. 11. Internal reviews conducted to verify QMS conformity
  8. 12. A change that could affect packaging performance must undergo this
  9. 16. Standard governing packaging for terminally sterilized devices