Regulatory & Compliance Document Library

Policies, SOPs, FDA submissions, audit reports, and certificates โ€” available as PDF downloads and linked HTML policy pages

Scraper Testing Note This library contains 8 locally hosted PDF documents and cross-links to HTML policy pages. External FDA reference URLs are included for link-following tests. All document metadata is visible in raw HTML without JavaScript.

Internal Policy Documents (PDF)

Official policy and SOP documents available for download. HTML versions contain identical obligation text with data-policy attributes for micropolicy extraction validation.

FDA & Quality System Documents (PDF)

510(k) Submission Summaries (PDF)

Clinical & Research Documents (PDF)

External FDA Reference Links

Official FDA resources for cross-reference during compliance reviews and scraper link-following tests.

Resource URL Relevance
FDA 21 CFR Part 820 (QSR) ecfr.gov/.../part-820 Quality System Regulation
FDA 510(k) Database accessdata.fda.gov/510k Premarket notification search
FDA MAUDE Database accessdata.fda.gov/MAUDE Adverse event reports
FDA GUDID accessgudid.nlm.nih.gov Unique Device Identification
HHS HIPAA Security Rule hhs.gov/hipaa/security PHI security requirements

Document Inventory Summary

Category PDF Count HTML Pages Total Policy Obligations Last Updated
Data Protection & Privacy2245+Jan 2026
FDA & Quality Systems3435+Jan 2026
510(k) Submissions13 device pages15+Mar 2024
Clinical Trials1112+Nov 2024
HIPAA1โ€”8+Jan 2026
IT & Security Policies0560+Jan 2026