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Michael Lehotay edited this page Oct 1, 2025
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Welcome to the Red Witch Wiki, your central hub for documentation, quality management, project planning, compliance, and operational guidance for the Red Witch project at Floating Eye Software (FLEY).
This wiki organizes all key information for team members, auditors, and stakeholders, including SOPs, Work Instructions (WIs), project plans, templates, compliance references, and records.
Learn about Red Witch’s commitment to quality, compliance, and continuous improvement.
- Quality Manual – Comprehensive overview of FLEY’s Quality Management System (QMS).
- Document Control SOP – Standard Operating Procedure for managing controlled documents.
- Quality Planning SOP – Guidance for creating and maintaining quality plans.
- Traceability SOP – Procedure for maintaining bidirectional regulatory traceability.
- GitHub Work Instructions – Step-by-step guidance for implementing SOPs and project workflows in GitHub.
- Ontario Design Framework – Work Instructions for the Ontario Design Framework (ODF) integration.
Core documentation and records for the Red Witch project.
- Red Witch Master Document List – Central index linking all Red Witch project documentation.
- Red Witch Quality Plan – Project-specific quality plan for Red Witch.
- Red Witch Privacy – Privacy considerations and protections for Red Witch.
- Red Witch Accessibility – Accessibility requirements and considerations.
- Red Witch Users – User analysis and personas for Red Witch.
- Red Witch Requirements – Functional and non-functional requirements.
- Red Witch Roadmap – Development roadmap and milestones.
- Red Witch Risk Management – Risk analysis and mitigations for Red Witch.
- Red Witch Post-Market Surveillance – Strategy and reporting for monitoring product performance.
Resources for planning and executing Red Witch projects effectively.
- Red Witch Quality Plan – Project-specific quality plan for Red Witch.
- Red Witch Pilot SOP Plan – Pilot plan for drafting and testing SOPs.
- Continuous Improvement Plan – Organization-wide plan for maturity and compliance reviews.
- Project Quality Plan Template – Template for creating new project-level quality plans.
- Quality Plan Template – Template for general quality plans.
Reference documents for key international and regional compliance frameworks.
- 21 CFR 820 – FDA Quality System Regulation (QSR) for medical devices.
- ISO 13485 – International standard for medical device quality management systems.
- ISO 14971 – Risk management standard for medical devices.
- ISO 9001 – International standard for quality management systems.
- IEC 62304 – Medical device software lifecycle processes.
- Ontario DSS – Ontario Digital Service Standard compliance framework.
- Use the headings above to navigate by topic.
- Links within each page provide traceability to issues, milestones, and GitHub PRs.
- The Quality Manual is the best starting point for understanding FLEY’s QMS framework.