Medical Device Regulatory Documentation
ISO 13485:2016 Quality Management System Procedures
Management Review Process
Risk Management Process
Internal Audit Process
- Audit Management Procedure
- Annual Audit Planning Template
- Audit Plan Template
- Audit Report Template
- Internal Audit Full Package (Procedure + Templates)
Human Resources / Training Process
- Human Resources and Training Management Procedure
- Training Record Template
- Training Matrix Template
- Training Plan Template
- Organizational Chart Template
- Human Resources Process Full Package (Procedure + Templates)
Software Validation Procedure
- Computer System Validation Procedure
- Computer System Validation Plan
- Computer System Validation Report
- Computer System Validation Process Full Package (Procedure + Templates)
CAPA Process
- Corrective and Preventive Actions Procedure
- CAPA Template
- Capa Database Template
- CAPA Process Full Package (Procedure + Templates)
Non-Conformity Process
- Non-Conformity Management Procedure
- Non-Conformance Report Template
- Non-Conformance Database Template
- Non-conformity Process Full Package (Procedure + Templates)
Change Management Process
- Change Control Procedure
- Notified Body Change Notification Procedure
- Change Control Template
- Change Control Database Template
- Change Control Process Full Package (Procedure + Templates)
Document Control Process
- Document Control Procedure
- Approval Template Sheet
- Document Master List Template
- Document Control Process Full Package (Procedure + Templates)
Complaint Management Process
- Complaint Management Procedure
- Complaint Handling Template
- Database Customer Complaints
- Database Customer Feedback
- Complaint Management Process Full Package (Procedure + Templates)
Vigilance Reporting Process
- EU Vigilance Reporting Procedure
- US Vigilance Reporting Procedure
- Japan Vigilance Reporting Procedure
- Procedure for Management of Field Actions/Advisory Notices
- Vigilance Reports Database Template
- Vigilance Management Process Full Package
Design Control Process
- Design Control Procedure
- Design and Development Plan Template
- Design Inputs Template
- Design Verification Plan Template
- Design Transfer Checklist
- Traceability Matrix Template
- Design Review Template
- Biological Risk Assessment Template
- Bill of Material Template
- Design History File Index Template
- Device Master Record Index Template
- Design Control Process Full Package (Procedure + Templates)
Supplier Management Process
- Supplier Management Procedure
- Initial Supplier Evaluation Template
- Supplier Monitoring Template
- Supplier List Template
- Supplier Management Process Full Package (Procedure + Templates)
Data Analysis Process
- KPI & Data Analysis Procedure
- KPI List & Data Analysis Template
- Risk Analysis QMS Processes Template
- Data Analysis Management Full Package
Process Validation
- Process Validation Procedure
- IQ Template
- OQ Validation Plan Template
- OQ Validation Report Template
- PQ Validation Plan Template
- PQ Validation Report Template
- Process Validation Full Package
Clinical Evaluation & Investigation Process
- Clinical Investigation Procedure
- Clinical Evaluation Procedure
- Investigator Brochure Template
- Clinical Evaluation Plan Template
- Clinical Evaluation Report Template
- Clinical Evaluation & Investigation Full Package
UDI Management Process
- UDI Management Procedure
- UDI Database Template
- UDI Management Full Package
Post-Market Surveillance Process
Management of Technical Dossier
Customer-Related Process
Labelling Management Process
- Labelling and Management of Translations Procedure
- E-Labelling Management Procedure
- Instructions for Use Template
- Labelling Management Process Full Package
Sterilization Process
- Validation of Ionizing Sterilization Procedure
- Validation of Ethylene Oxide Sterilization Procedure
Infrastructure, Work Environment and Equipment Management
- Infrastructure and Work Environment Procedure
- Control of Equipment Procedure
- Equipment Database Template
Manufacturing Operations
Usability Management
- Usability Procedure
- Usability File Template
- User Related Risk Analysis Template
Management of Communication
Purchase Management
Purchase Order Template
Strategy for Regulatory Compliance
EU MDR 2017/745 Documentation
EU IVDR 2017/746 Documentation
- GSPR Checklist for EU IVDR 2017/746
- Performance Evaluation Plan Template
- PRRC Designation Letter (for IVDR)
- Strategy for Regulatory Compliance (for IVDR)
- Checklist for Technical Documentation According to EU IVDR 2017/746
Technical Documentation Templates
Risk Management Report Template
Design & Development Plan Template
Design verification Plan Template
Postmarket Surveillance Plan Template
Periodic Safety Update Report Template
Postmarket Surveillance Report Template
Biological Risk Assessment Template
Investigation Brochure Template
Software Development Plan Template
Software Architecture Template
Compliance Checklist
Quality Agreements / Contract Templates
- External PPRC Agreement Template
- Quality Agreement (Manufacturer)
- Distributor Quality Agreement
- Importer Quality Agreement
ISO 27001 and Medical Device Cybersecurity
ISO 27001 Documentation
Medical Device Cybersecurity Documentation
- Cybersecurity Risk Management Plan
- Threat Model Report Template
- Vulnerability Disclosure Policy Template
- Management of Cybersecurity Vulnerabilities
- Cybersecurity Risk Analysis (Risk Assessment)
