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


American Society for Quality
U.S. Food and Drug Administration
FDA Inspection Guides
FDA Warning Letters
Medical Device Industry Supplier Directory
The Parenteral Drug Association
Regulatory Affairs Professionals Society
Medical Device Regulations by Country
European Commission
European Compliance Academy
FDA CDER Guidance Documents
FDA CDRH Guidance Documents
FDA Vaccines, Blood and Biologics Guidance Documents
FDA Debarment List