Collection: ISO 13485 Templates
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Change Control Log Template - ISO 13485
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Check List for ISO 13485:2016+A11:2021
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Complaint Handling Procedure - ISO 13485
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Complaint Investigation Form - ISO 13485
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Control of Measuring and Monitoring Equipment Procedure - ISO 13485
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Control of Records Procedure - ISO 13485
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Corrective Action and Preventative Action (CAPA) Procedure - ISO 13485
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Corrective and Presentative Action (CAPA) Report Log - ISO 13485
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Corrective and Preventative Action (CAPA) Report Form - ISO 13485
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Customer Feedback Procedure - ISO 13485
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Customer Related Process Procedure - ISO 13485
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Declaration of Conformity Template - IVDR 2017/746
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Declaration of Conformity Template - MDR 2017/745
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Design and Development Procedure - ISO 13485
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Device History Record Procedure - ISO 13485
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Document Control Procedure - ISO 13485
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Employee Induction - ISO 13485
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Feedback & Complaints Database - ISO 13485
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Goods In, Goods Out & Preservation of Product Procedure - ISO 13485
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GSPR Checklist Template - IVDR 2017/746
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GSPR Checklist Template - MDR 2017/745
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Infrastructure, Work Environment and Contamination Control Procedure - ISO 13485
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Internal Audit Plan- ISO 13485
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Internal Audit Procedure - ISO 13485
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