Download QMS
Export Osteofy Quality Management System documents for offline access, audit, or regulatory submission
Complete QMS Archive
Download the entire Osteofy QMS as a single ZIP archive containing all 77 controlled documents organized in their proper folder hierarchy, ready for regulatory submission or audit review.
Archive Contents
QMS Overview
Complete index, document map, critical path
Quality Manual
QM-001, QM-002 — QMS foundation
Organization
ORG-001 to ORG-003 — roles, RACI, appointments
Document Control
DOC-001 to DOC-003 — document and record control
Design Controls
DC-001 to DC-009 — ISO 13485 Clause 7.3
Software Lifecycle
SW-001 to SW-010 — IEC 62304 Class B
Risk Management
RM-001 to RM-006 — ISO 14971:2019
Operations
PO-001 to PO-005 — infra, change, incident, backup
Security & Privacy
SEC-001 to SEC-005 — HIPAA, GDPR
AI/ML Governance
AI-001 to AI-005 — AI lifecycle and clinical validation
CAPA
CAPA-001 to CAPA-003 — corrective and preventive actions
Audit
AUD-001 to AUD-002 — internal audit procedures
Regulatory
REG-001 to REG-011 — FDA, EU MDR, ANVISA, TGA
Templates
TMPL-001 to TMPL-010 — 10 standardized forms
Validation
VAL-001 to VAL-003 — IQ, OQ, PQ protocols
README + MANIFEST
Export metadata and file index with checksums
Export by Category
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
Audit-Ready Export Format
All exported documents retain their original controlled document metadata, version numbers, ISO clause references, revision histories, and classification markings. The MANIFEST.json file provides a complete index for integrity verification.