Project Name: Red Witch Document Owner: QA/RA Manager Project Location: Ontario, Canada Regulatory Framework: ISO 13485, ISO 14971, IEC 62304, ISO/IEC 29148, HIPAA, GDPR, PIPEDA, PHIPA, Health Canada, EU MDR Version: Draft 0.1
| Doc ID | Title | Purpose | Status | Link | |————|——————————|————————————————-|——–|——| | RW-QMS-001 | Quality Manual | Defines the QMS framework for Red Witch | Draft | Open | | RW-QMS-002 | Document Control Procedure | Ensures controlled creation, approval, revision | Draft | Open | | RW-QMS-003 | Training Records | Evidence of staff competency and training | TBD | Open | | RW-QMS-004 | Supplier & Outsourcing Proc. | Defines supplier approval & control | Draft | Open |
| Doc ID | Title | Purpose | Status | Link | |————|——————————–|————————————————|——–|——| | RW-SRS-001 | Software Requirements Spec. | Defines functional, security, regulatory reqs. | Draft | Open | | RW-ARC-001 | Software Architecture Doc. | Describes components, data flow, interfaces | TBD | Open | | RW-SDD-001 | Software Design Description | Detailed low-level design | TBD | Open | | RW-IMP-001 | Source Code Repository | Controlled source code management | Ongoing| Open | | RW-VER-001 | Verification & Validation Plan | Defines testing and acceptance criteria | TBD | Open | | RW-VER-002 | Verification & Validation Rept | Test results linked to requirements | TBD | Open |
| Doc ID | Title | Purpose | Status | Link | |————|——————————|————————————————|——–|——| | RW-RMF-001 | Risk Management Plan | Defines methodology for risk assessment | Draft | Open | | RW-RMF-002 | Risk Management File (RMF) | Identifies hazards, risks, and mitigations | Draft | Open | | RW-RMF-003 | Hazard Traceability Matrix | Maps risks → requirements → mitigations | Draft | Open |
| Doc ID | Title | Purpose | Status | Link | |————|——————————–|————————————————|——–|——| | RW-REG-001 | Regulatory Strategy | Defines classification (Canada, EU, U.S.) | Draft | Open | | RW-REG-002 | GDPR/PIPEDA Compliance Plan | Data protection measures | Draft | Open | | RW-REG-003 | HIPAA Compliance Plan | Requirements for U.S. market | Draft | Open | | RW-REG-004 | Health Canada Submission File | For Medical Device License application | TBD | Open |
| Doc ID | Title | Purpose | Status | Link | |————|———————————–|—————————————-|——–|——| | RW-SEC-001 | Security Architecture Document | Describes encryption, key mgmt, threats| TBD | Open | | RW-SEC-002 | Data Protection Impact Assessment | GDPR Art. 35 privacy risk assessment | Draft | Open | | RW-SEC-003 | Threat Model & Pen Test Report | Validates security controls | TBD | Open |
| Doc ID | Title | Purpose | Status | Link | |————|—————–|—————————————–|——–|——| | RW-UM-001 | User Manual | Instructions for safe and compliant use | Draft | Open | | RW-UM-002 | Privacy Policy | Transparency on data handling | Draft | Open | | RW-UM-003 | Terms of Service| Legal agreement with users | Draft | Open |
✅ Usage: This index provides a controlled overview of all QMS documents for the Red Witch project. Each document must be version-controlled, reviewed, and approved per RW-QMS-002 (Document Control Procedure).