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Collection: ISO 13485 Templates

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ISO 13485 (Clause 4.1) - Master Software List Template

ISO 13485 (Clause 4.1) - Master Software List Template

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ISO 13485 (Clause 4.1) - Master Software List Template for High Risk Devices

ISO 13485 (Clause 4.1) - Master Software List Template for High Risk Devices

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ISO 13485 (Clause 4.1) - Risk Analysis Template - Software

ISO 13485 (Clause 4.1) - Risk Analysis Template - Software

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ISO 13485 (Clause 4.1) - Software Acceptance Testing

ISO 13485 (Clause 4.1) - Software Acceptance Testing

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ISO 13485 (Clause 4.1) - Software Validation Procedure

ISO 13485 (Clause 4.1) - Software Validation Procedure

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ISO 13485 (Clause 4.1) - Software Validation Procedure for High Risk Devices

ISO 13485 (Clause 4.1) - Software Validation Procedure for High Risk Devices

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ISO 13485 (Clause 4.2) - Change Control Log Template

ISO 13485 (Clause 4.2) - Change Control Log Template

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ISO 13485 (Clause 4.2) - Control of Records Procedure

ISO 13485 (Clause 4.2) - Control of Records Procedure

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ISO 13485 (Clause 4.2) - Document Control Procedure

ISO 13485 (Clause 4.2) - Document Control Procedure

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ISO 13485 (Clause 4.2) - Document Review Guidance Template

ISO 13485 (Clause 4.2) - Document Review Guidance Template

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ISO 13485 (Clause 4.2) - Master Document List Template

ISO 13485 (Clause 4.2) - Master Document List Template

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ISO 13485 (Clause 4.2) - Post Market Surveillance Plan Template

ISO 13485 (Clause 4.2) - Post Market Surveillance Plan Template

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ISO 13485 (Clause 4.2) - Quality Manual Template

ISO 13485 (Clause 4.2) - Quality Manual Template

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ISO 13485 (Clause 5.0) - Management Responsibilities Procedure

ISO 13485 (Clause 5.0) - Management Responsibilities Procedure

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ISO 13485 (Clause 5.3) - Quality Policy Template

ISO 13485 (Clause 5.3) - Quality Policy Template

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ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log

ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log

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ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Procedure

ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Procedure

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ISO 13485 (Clause 5.4) - Planned Deviation Request Form

ISO 13485 (Clause 5.4) - Planned Deviation Request Form

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ISO 13485 (Clause 5.4) - QMS Change Request Form

ISO 13485 (Clause 5.4) - QMS Change Request Form

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ISO 13485 (Clause 5.4) - Quality Management Planning Procedure Template

ISO 13485 (Clause 5.4) - Quality Management Planning Procedure Template

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ISO 13485 (Clause 5.4) - Quality Objectives & Planning Template

ISO 13485 (Clause 5.4) - Quality Objectives & Planning Template

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ISO 13485 (Clause 5.6) - Management Review Meeting Agenda Template

ISO 13485 (Clause 5.6) - Management Review Meeting Agenda Template

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ISO 13485 (Clause 5.6) - Management Review Meeting Minutes Template

ISO 13485 (Clause 5.6) - Management Review Meeting Minutes Template

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ISO 13485 (Clause 5.6) - Management Review Meetings Schedule

ISO 13485 (Clause 5.6) - Management Review Meetings Schedule

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