Medical Device Quality Management System – Class I or II Medical Device (electrical), US Distribution, without Software
Set of 6 checklists with 1 hour of telephone or email support: $595.00 or $195.00 per checklist. For additional information, please call 415.388.1695 or email.
Checklist 1: 21 CFR 820 The Quality System Regulation and 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes
Checklist 2: Quality System Inspection Technique (QSIT) – US FDA Field Investigator inspection technique
Checklist 3: 21 CFR 803 and 806 – Medical Device Reporting / Recall
Checklist 4: ISO 14971:2009 Medical devices – Application of risk management to medical devices
Checklist 5: 21 CFR 820.30 Design control + EN 60601-1 Third Edition
Checklist 6: 510(k) Traditional or Abbreviated Readiness