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  Checklist – EU IVDD – Essential Principles (v.1.0)

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  Checklist – ISO 13485 2016 Internal Audit (v.1.0)

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• 

  Gap Analysis Tool – QSR 21 CFR 820 vs ISO 13485 2016 (v1.0)

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  Template – Product Qualification and Classification under the EU IVDR 2017/746 (v.1.0)

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  Template – SOP Control of Records (v.1.0)

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  Template – SOP Controlled Documents (v.1.0)

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  Template – SOP Master Validation Test Plan (v.1.0)

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  Template – SOP Technical Documentation according the IVDR (v1.0)

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• 

  Template – Supplier Quality Assurance Agreement Word (v.1.0)

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• 

  Template – Technical Documentation Table of Content according to the IVDR (v1.0)

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