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