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Published byJamal Truran Modified over 10 years ago
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REGULATIONS for SUPPLIES, EQUIPMENT, REAGENTS and TESTING JILL HOAG BS, SBB(ASCP) CQA(ASQ) AABB STAFF LEAD ASSESSOR 1
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MEDICAL DEVICES EQUIPMENT SUPPLIES REAGENTS TEST KITS 2
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AUTHORITY GIVEN BY FDCA FDA CDRH ODE 3
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PREMARKET APPROVAL PREMARKET NOTIFICATION 510(k) CLEARED VARIANCES 4
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21 CFR 820 REQUIREMENTS 5
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QUALITY SYSTEM MANAGEMENT RESPONSIBILITY QUALITY AUDITS PERSONNEL 6
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DESIGN CONTROLS DESIGN: PLANNING INPUT OUTPUT REVIEW VERIFICATION &VALIDATION TRANSFER TO PRODUCTION CHANGES 7
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DOCUMENT CONTROLS PURCHASING CONTROLS IDENTIFICATION TRACEABILITY 8
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PRODUCTION CONTROLS: CHANGE CONTROL ENVIRONMENTAL CONTROL CONTAMINATION CONTROL 9
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PRODUCTION CONTROLS: MATERIAL INSPECTION SOFTWARE VALIDATION INSPECTION 10
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PROCESS CONTROLS: WRITTEN INSTRUCTIONS (SOPS) MONITORING REFERENCE STANDARDS APPROVAL of PROCESS & EQUIPMENT SAMPLING for WORKMANSHIP 11
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MEASURING EQUIPMENT CALIBRATION CALIBRATION STANDARDS CALIBRATION RECORDS 12
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ACCEPTANCE ACTIVITIES REVIEW of DATA RELEASE by SIGNATURE RECORDS ACCEPTANCE STATUS 13
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PACKAGING HANDLING STORAGE DISTRIBUTION INSTALLATION 14
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NONCONFORMING DEVICE CAPA CUSTOMER COMPLAINTS SERVICING 15
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510(K) SUBMISSION: DEVICE & DATA PRESENTED REVIEWED CLEARED 16
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EXAMPLE : 510(k) CLEARED REAGENT C3b CONTROL CELLS CLASS II DESCRIPTION USE SUMMARY OF TECHNICAL CHARACTERISTICS SUMMARY OF PERFORMANCE REACTIVITY STABILITY 19
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