New MWA Products: Medical Device Checklists

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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