1. MEDICAL DEVICES REGULATIONS for SUPPLIES, EQUIPMENT, REAGENTS and TESTING JILL HOAG BS, SBB(ASCP) CQA(ASQ) AABB STAFF LEAD ASSESSOR

2. MEDICAL DEVICE REGULATION • MEDICAL DEVICES • EQUIPMENT • SUPPLIES • REAGENTS • TEST KITS

3. MEDICAL DEVICE REGULATION • AUTHORITY GIVEN BY FDCA • FDA • CDRH • ODE

4. MEDICAL DEVICE REGULATION • PREMARKET APPROVAL • PREMARKET NOTIFICATION • 510(k) CLEARED • VARIANCES

5. MEDICAL DEVICE REGULATION • 21 CFR 820 • REQUIREMENTS

6. MEDICAL DEVICE REGULATION • QUALITY SYSTEM • MANAGEMENT RESPONSIBILITY • QUALITY AUDITS • PERSONNEL

7. MEDICAL DEVICE REGULATION • DESIGN CONTROLS • DESIGN: • PLANNING • INPUT • OUTPUT • REVIEW • VERIFICATION &VALIDATION • TRANSFER TO PRODUCTION • CHANGES

8. MEDICAL DEVICE REGULATION • DOCUMENT CONTROLS • PURCHASING CONTROLS • IDENTIFICATION • TRACEABILITY

9. MEDICAL DEVICE REGULATION • PRODUCTION CONTROLS: • CHANGE CONTROL • ENVIRONMENTAL CONTROL • CONTAMINATION CONTROL

10. MEDICAL DEVICE REGULATION • PRODUCTION CONTROLS: • MATERIAL INSPECTION • SOFTWARE VALIDATION • INSPECTION

11. MEDICAL DEVICE REGULATION • PROCESS CONTROLS: • WRITTEN INSTRUCTIONS (SOPS) • MONITORING • REFERENCE STANDARDS • APPROVAL of PROCESS & EQUIPMENT • SAMPLING for WORKMANSHIP

12. MEDICAL DEVICE REGULATION • MEASURING EQUIPMENT • CALIBRATION • CALIBRATION STANDARDS • CALIBRATION RECORDS

13. MEDICAL DEVICE REGULATION • ACCEPTANCE ACTIVITIES • REVIEW of DATA • RELEASE by SIGNATURE • RECORDS • ACCEPTANCE STATUS

14. MEDICAL DEVICE REGULATION • PACKAGING • HANDLING • STORAGE • DISTRIBUTION • INSTALLATION

15. MEDICAL DEVICE REGULATION • NONCONFORMING DEVICE • CAPA • CUSTOMER COMPLAINTS • SERVICING

16. MEDICAL DEVICE REGULATION • 510(K) SUBMISSION: • DEVICE & DATA PRESENTED • REVIEWED • CLEARED

19. MEDICAL DEVICE REGULATION EXAMPLE: • 510(k) CLEARED REAGENT • C3b CONTROL CELLS • CLASS II • DESCRIPTION • USE • SUMMARY OF TECHNICAL CHARACTERISTICS • SUMMARY OF PERFORMANCE • REACTIVITY • STABILITY

20. MEDICAL DEVICE REGULATION