QMS · DOCUMENTS
Every document.
Every file. One source of truth.
SOPs, design files, risk records, tech files, regulatory submissions — versioned, approved, training-linked, audit-ready. Organize them into Bills of Documents. Find anything in plain English. Let Iris draft, update, and verify in bulk.
BioVeritas Diagnostics, Inc.
Quality Management System Manual
CONTROLLED DOCUMENT
BioVeritas Diagnostics, Inc.
QUALITY MANAGEMENT SYSTEM MANUAL
In Vitro Diagnostic Medical Devices
| Doc No. | Rev | Effective | Status |
| QM-001 | A | 2024-01-15 | APPROVED |
Applicable Standards: ISO 13485:2016 | 21 CFR Part 820 | IVDR 2017/746
1. Purpose and Scope
This Quality Management System (QMS) Manual establishes the framework for BioVeritas Diagnostics, Inc. to consistently design, develop, manufacture, and distribute safe and effective In Vitro Diagnostic (IVD) medical devices...
✦
Ask Iris
×
QUICK ACTIONS
instant, single-step
Summarize this document
Generate a concise summary of key procedures, scope, and regulatory references
Chat about this document
Ask anything — requirements, scope, procedures, regulatory references
AGENTIC WORKFLOWS
multi-step, approval gates
Update this Document
Draft updates through AI-assisted redlines → review changes inline → auto-create Change Order with pre-filled details → route for approval
Coming soon
INFORMATION
Document Control panel
Document Control
Information
Document
Attachments
Links
Training
Activity
Revisions
Top-level Quality Management System manual establishing the framework for design, development, manufacturing, and distribution of IVD medical devices per ISO 13485:2016.
WHAT YOU GET
Document control, modernized.
Everything you'd expect from a controlled-document system. Plus an AI agent that does the work no one wants to do.
● CORE
The fundamentals, done right.
Version comparison & redlines
Side-by-side diff with line-level redlines. Every revision tracked. Roll back anytime.
Audit trail
Every action logged. Every signature timestamped. Every reviewer named. 21 CFR Part 11 native.
Periodic review
Schedule, notify, escalate. 3-year cycles enforced automatically. Never miss a review again.
Document linking
Cross-reference docs to each other. See what depends on what. Trace before you change.
AI-POWERED
Where Iris does the heavy lifting.
AI-assisted writing
Draft SOPs, design specs, risk records. Iris cites source clauses and flags missing sections.
Bulk QMS generation
Spinning up a QMS from scratch? Iris generates a full ISO 13485-aligned set of SOPs tailored to your scope.
Bulk document updates
New regulation? Iris finds every doc it touches and proposes redlines for batch review.
Document Q&A
Ask Iris a question about any doc. Get a cited answer in seconds — no scrolling through PDFs.
Semantic search
Search in plain English across documents, CAPAs, training, suppliers — all at once.
AI quiz generation
Auto-build competency quizzes from any doc — multiple choice, scenario-based. Tied to revisions.
Auto-retraining triggers
Doc revision lands → Iris identifies who needs retraining → workflow queued with the new quiz attached.
Compliance check
Audit any doc or BOD against ISO 13485, IEC 62304, EU MDR. Get a gap list with citations.
★ FLAGSHIP CAPABILITY
Bill of Documents.
Living, versioned collections of documents that belong together — your QMS Procedures, your Design History File, your Tech File, your Risk Management File. Snapshot the exact state for an audit. Let Iris check the whole stack.
✦ AI compliance check
Iris audits the whole BOD against ISO 13485, EU MDR, etc. and lists exact gaps.
✦ Snapshot for audits
Freeze the exact state for an audit or 510(k) submission. Reproducible forever.
✦ Auto-versioning
Daily snapshots when docs change. Major bumps when structure changes.
▾
Planning
1
Design & Development Plan
DDP-0001
Released
▾
Design Inputs
2
User Needs
UN-0001
Released
Product Requirements Spec
PRS-0001
Released
▾
Design Outputs
2
Hardware Design Spec
HDS-0001
Released
Software Design Spec
SDS-0001
Released
▾
Design Verification
1
V&V Protocol & Report
VVP-0001
Released
▾
Design Validation
1
Clinical Validation Report
CVR-0001
Released
See Iris run a real document workflow.
Bring your messiest SOP — or your most fragmented DHF. We'll show you the difference.