| Management Review Process | Management Review Procedure |
| Management Review Template |
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| Risk Management Process | Risk Management Procedure |
| Risk Management Plan Template
Risk Management Report Template
Risk Analysis Template
Hazard Analysis Template
Traceability Matrix Template |
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| Internal Audit Process | Audit Management Procedure |
| Annual Audit Planning Template
Audit Plan Template
Audit Report Template |
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| Human Resources / Training Process | Human Resources and Training Management Procedure |
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| Software Validation Procedure | Computer System Validation Procedure |
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| CAPA Process | Corrective and Preventive Actions Procedure |
| CAPA Template
Capa Database Template |
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| Non-Conformity Process | Non-Conformity Management Procedure |
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| Change Management Process | Change Control Procedure
Notified Body Change Notification Procedure |
| Change Control Template
Change Control Database Template |
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| Document Control Procedure |
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| Complaint Management Process | Complaint Management Procedure |
| Complaint Handling Template
Database Customer Complaints
Database Customer Feedback |
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| Vigilance Reporting Process | EU Vigilance Reporting Procedure
Procedure for Management of Field Actions/Advisory Notices |
| Data Sanitization and Disposal |
| Design Control Process | Design Control Procedure |
| Design and Development Plan Template
Design Inputs Template
Design Verification Plan Template
Design Transfer Checklist
Design Review Template
Biological Risk Assessment Template
Design History File Index Template
Device Master Record Index Template |
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| Supplier Management Process | Supplier Management Procedure |
| Initial Supplier Evaluation Template
Supplier Monitoring Template
Supplier List Template |
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| Data Analysis Process | KPI & Data Analysis Procedure |
| KPI List & Data Analysis Template
Risk Analysis QMS Processes Template |
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| Process Validation | Process Validation Procedure |
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| Clinical Evaluation & Investigation Process | Clinical Evaluation Procedure |
| Investigator Brochure Template |
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| UDI Management Process | UDI Management Procedure |
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| Post-Market Surveillance Process | Post-Market Surveillance Procedure |
| Post-market Surveillance Plan Template
Post-Market Surveillance Report Template
Periodic Safety Update Report (PSUR) Template |
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| Management of Technical Dossier | Medical Device File Procedure |
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| Customer-Related Process | Customer Related Process Procedure |
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| Labelling and Management of Translations Procedure
E-Labelling Management Procedure |
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| Sterilization Process | Validation of Ionizing Sterilization Procedure |
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| Infrastructure, Work Environment and Equipment Management | Infrastructure and Work Environment Procedure
Control of Equipment Procedure |
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| Manufacturing Operations | Production and Service Provision Procedure
Incoming Control Procedure |
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| Usability Management | Usability Procedure
Usability File Template |
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| Purchase Management | Purchase Management Procedure
Purchase Order Template |
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| Strategy for Regulatory Compliance | Strategy for Regulatory Compliance Procedure (Template) |
