Documentation Toolkit

• Management Review Procedure
• Management Review Template
• Management Review Full Package (Procedure + Template)

• Risk Management Procedure
• Risk Management Plan Template
• Risk Management Report Template
• Risk Analysis Template
• Hazard Analysis Template
• Traceability Matrix Template
• Risk Management Full Package (Procedure + Templates)

• Audit Management Procedure
• Annual Audit Planning Template
• Audit Plan Template
• Audit Report Template
• Audit Management Process Package (Procedure + Templates)

• Human Resources and Training Management Procedure
• Training Record Template
• Training Plan Template
• Organizational Chart Template
• Human Resources Process Package (Procedure + Templates)

• Computer System Validation Procedure 
• Computer System Validation Plan
• Computer System Validation Report
• Computer System Validation Process Full Package (Procedure + Templates)

• Corrective and Preventive Actions Procedure
• CAPA Template
• Capa Database Template
• CAPA Process Full Package (Procedure + Templates)

• Non-Conformity Management Procedure 
• Non-Conformance Report Template
• Non-Conformance Database Template
• Non-conformity Process Full Package (Procedure + Templates)

• Change Control Procedure 
• Notified Body Change Notification Procedure
• Change Control Template
• Change Control Database Template
• Change Control Process Full Package (Procedure + Templates)

• Document Control Procedure
• Approval Template Sheet
• Document Master List Template
• Document Control Process Full Package (Procedure + Templates)

• Complaint Management Procedure
• Complaint Handling Template
• Database Customer Complaints
• Database Customer Feedback
• Complaint Management Process Full Package (Procedure + Templates)

• 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 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 Procedure 
• Initial Supplier Evaluation Template
• Supplier Monitoring Template
• Supplier List Template
• Supplier Management Process Full Package (Procedure + Templates)

• KPI & Data Analysis Procedure
• KPI List & Data Analysis Template
• Risk Analysis QMS Processes Template
• Data Analysis Management Full Package

• 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 Investigation Procedure
• Clinical Evaluation Procedure
• Investigator Brochure Template
• Clinical Evaluation Plan Template
• Clinical Evaluation Report Template
• Clinical Evaluation & Investigation Full Package

• UDI Management Procedure
• UDI Database Template
• UDI Management Full Package

• Post-Market Surveillance Procedure
• Post-market Surveillance Plan Template
• Post-Market Surveillance Report Template
• Periodic Safety Update Report (PSUR) Template

• Medical Device File Procedure

• Customer Related Process Procedure

• Labelling and Management of Translations Procedure
• E-Labelling Management Procedure
• Instructions for Use Template
• Labelling Management Process Full Package

• Validation of Ionizing Sterilization Procedure
• Validation of Ethylene Oxide Sterilization Procedure

• Infrastructure and Work Environment Procedure
• Control of Equipment Procedure
• Equipment Database Template

• Production and Service Provision Procedure
• Incoming Control Procedure

• Usability Procedure 
• Usability File Template
• User Related Risk Analysis Template

Purchase Management Procedure

Purchase Order Template

• Strategy for Regulatory Compliance Procedure (Template)