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.
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
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