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 .. 11 49 PRODUCT PLANNING .. 11 50 RISK management : A PATIENT SAFETY FOCUSED PROCESS .. 12 51 DOCUMENT CONTROL AND RECORDS .. 13 52 CONFIGURATION management AND CONTROL .. 14 53 MEASUREMENT, ANALYSIS AND IMPROVEMENT OF PROCESSES AND PRODUCT.
IMDRF/SaMD WG (PD1)/N23R3 6 156 equivalent activities in a medical device quality management system (e.g., identifying 157 ‘design inputs’) used in the management, design, development, implementation,
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