Downloads

Technical Documentation

Digital Template for the Technical Documentation (Annex II): Designed to Align with the Standards of Regulation (EU) 2017/746 (IVDR) on In Vitro Diagnostic Medical Devices. We offer an intuitive Technical Documentation Template, customized to accommodate your unique IVD medical devices. This template serves as an invaluable tool in facilitating the compliance process, ensuring the creation […]
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General Safety and Performance Requirements Checklist

Digital Template for General Safety and Performance Requirements (GSPR): Designed to Align with the Standards of Regulation (EU) 2017/746 (IVDR) on In Vitro Diagnostic Medical Devices. This meticulously crafted template provides a simplified approach to the GSPR under the IVDR. This is a pivotal element in maintaining compliance with EU regulations specific to In Vitro […]
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Classification

Digital Template for IVD Classification: Designed to Align with the Standards of Regulation (EU) 2017/746 (IVDR) on In Vitro Diagnostic Medical Devices. We offer an intuitive IVD Classification Template, customized to accommodate your unique IVD medical devices. This template serves as an invaluable tool in facilitating the compliance process, ensuring the creation of precise, regulation-compliant […]
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Intended Purpose Statement

Digital Template for establishing the Intended Purpose: Designed to Align with the Standards of Regulation (EU) 2017/746 (IVDR) on In Vitro Diagnostic Medical Devices. We offer an intuitive Intended Purpose Template, customized to accommodate your unique IVD medical devices. This template serves as an invaluable tool in facilitating the compliance process, ensuring the creation of […]
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EU Declaration of Conformity (IVDR)

Digital Template for establishing the EU Declaration of Conformity: Designed to Align with the Standards of Regulation (EU) 2017/746 (IVDR) on In Vitro Diagnostic Medical Devices. We offer an intuitive EU Declaration of Conformity Template, customized to accommodate your unique IVD medical devices. This template serves as an invaluable tool in facilitating the compliance process, […]
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