Transcription of Proposed document: Software as a Medical Device …
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Proposed document: Software as a Medical Device …
1. 2 IMDRF/SaMD WG (PD1)/N23R3. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13 Proposed DOCUMENT. 14 International Medical Device Regulators Forum 15. 16. 17. 18 Title: Software as a Medical Device (SaMD): Application of Quality 19 Management System 20. 21 Authoring Group: IMDRF SaMD Working Group 22. 23 Date: 26 March, 2015. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. IMDRF/SaMD WG (PD1)/N23R3. 36. 37 Table of Contents 38 INTRODUCTION .. 4 39 SCOPE .. 5 40 REFERENCES .. 6 41 7 42 SAMD QUALITY MANAGEMENT PRINCIPLES .. 8 43 SAMD GOVERNANCE: LEADERSHIP AND ORGANIZATIONAL SUPPORT .. 9 44 LEADERSHIP AND ACCOUNTABILITY IN THE ORGANIZATION .. 9 45 RESOURCE AND INFRASTRUCTURE MANAGEMENT .. 9 46 PEOPLE .. 10 47 INFRASTRUCTURE AND WORK ENVIRONMENT .. 10 48 MANAGING SAMD LIFECYCLE PROCESSES.
1 2 IMDRF/SaMD WG (PD1)/N23R3 3 4 5 6 7 8 9 10 11 12 13 PROPOSED DOCUMENT 14 International Medical Device Regulators Forum 15 16 17 18 Title: Software as a Medical ...
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