Regulatory & Compliance Document Library
Policies, SOPs, FDA submissions, audit reports, and certificates โ available as PDF downloads and linked HTML policy pages
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.
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Privacy Policy v4.1 (PP-001)
Personal data protection standards โ collection, encryption, retention, subject rights, third-party transfers.
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Data Handling SOP v3.2 (SOP-DH-001)
Classification, storage, sharing, disposal procedures for Confidential, Internal, and Public data.
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HIPAA Security Rule Assessment 2026
Annual assessment of administrative, physical, and technical safeguards for PHI systems.
FDA & Quality System Documents (PDF)
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FDA QSR Audit Checklist 2026
21 CFR Part 820 compliance checklist covering design controls, purchasing, production, complaints, and statistical techniques.
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Medical Device Reporting Procedures (SOP-MDR-001)
Procedures for 21 CFR Part 803 MDR submissions including 30-day and 5-day reporting requirements.
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ISO 13485:2016 Certificate
Quality management system certification for design, development, and manufacture of medical monitoring devices.
510(k) Submission Summaries (PDF)
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510(k) Summary โ Veridian Pulse Monitor (K240847)
Substantial equivalence determination for VPM-4000 Series electrocardiograph. Predicate: K193847.
Clinical & Research Documents (PDF)
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Clinical Trial Protocol VRD-CT-2024-001
Phase II study: Efficacy of Veridian Glucose Patch in Type 2 Diabetes Management. IND 142847.
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 & Privacy | 2 | 2 | 45+ | Jan 2026 |
| FDA & Quality Systems | 3 | 4 | 35+ | Jan 2026 |
| 510(k) Submissions | 1 | 3 device pages | 15+ | Mar 2024 |
| Clinical Trials | 1 | 1 | 12+ | Nov 2024 |
| HIPAA | 1 | โ | 8+ | Jan 2026 |
| IT & Security Policies | 0 | 5 | 60+ | Jan 2026 |