Osteofy Quality Management System
Document Control Portal for the Osteofy Bone Mineral Density Analysis System — a Software as a Medical Device (SaMD). This QMS manages 119 controlled documents across 19 categories, ensuring audit-ready compliance with ISO 13485:2016, IEC 62304, ISO 14971:2019, and all target market regulatory requirements.
Document Categories
Quality Manual and Quality Policy establishing the QMS foundation
Organizational structure, roles, responsibilities, and management representation
Document and record control procedures and the QMS master index
Design control procedures per ISO 13485:2016 Clause 7.3 and Design History File
IEC 62304 Class B software development lifecycle documentation
ISO 14971:2019 risk management for the SaMD throughout its lifecycle
Server infrastructure, change control, incident response, and backup recovery
Data classification, access control, PHI handling, and HIPAA/GDPR compliance
AI/ML model governance, training data, performance monitoring, and clinical validation
Corrective and preventive actions, complaint handling, and adverse event reporting
Internal audit procedures and annual audit schedule
Regulatory strategy and preparedness for FDA 510(k), EU MDR, ANVISA, and TGA
Standard templates for design reviews, test protocols, CAPA forms, and more
Installation, operational, and performance qualification protocols and reports
Management review procedure and records per ISO 13485:2016 Clause 5.6
Human resources and training procedure per ISO 13485:2016 Clause 6.2
Purchasing control procedure and supplier management per ISO 13485:2016 Clause 7.4
Post-market surveillance procedure per ISO 13485:2016 Clause 8.2.5 and EU MDR Annex III
Analysis of data procedure and QMS KPI framework per ISO 13485:2016 Clause 8.4
Recent Documents
View all| Document | Category | Version | Status |
|---|---|---|---|
AI-001 AI Model Governance Plan | AI ML Governance | v1.0 | Approved |
AUD-001 Internal Audit Procedure | Audit | v1.0 | Approved |
QM-001 Quality Manual | Quality Manual | v1.0 | Approved |
QM-002 Quality Policy | Quality Manual | v1.0 | Approved |
CAPA-001 CAPA Procedure | CAPA | v1.0 | Approved |
CAPA-002 Complaint Handling Procedure | CAPA | v1.0 | Approved |
CAPA-003 Adverse Event Reporting Procedure | CAPA | v1.0 | Approved |
AUD-002 Annual Audit Schedule | Audit | v1.0 | Approved |
Regulatory Framework
| Standard | Title | Market | Documents | Status |
|---|---|---|---|---|
| ISO 13485:2016 | Quality Management Systems | Global | 77 | Active |
| IEC 62304:2006+A1 | Medical Device Software Lifecycle | Global | 10 | Active |
| ISO 14971:2019 | Risk Management | Global | 6 | Active |
| 21 CFR Part 820 | FDA Quality System Regulation | USA | 21 | Active |
| EU MDR 2017/745 | EU Medical Device Regulation | European Union | 7 | Active |
| HIPAA | Health Insurance Portability Act | USA | 5 | Active |