Software Development

FDA Qsr Audit Prep

FDA Quality System Regulation (21 CFR 820 / QMSR) audit-prep playbook for medical devices. Use when an FDA inspection is announced, when preparing for the new QMSR (2026), or when a 483 / Warning Letter response is needed.

Publisher / source
borghei/Claude-Skills (found on the CSV list)
Upstream record
borghei/Claude-Skills
Version
Version 2
Published
Publication review
Approved for publication
Content fingerprint
6bc5f935e3f5e5f1e0a66be1f674b054dc2b5cb894750a6573526282987c40d6