The Performance Evaluation Report outlines the methodologies and outcomes concerning the scientific validity, analytical performance, and clinical performance. A dedicated standard for this is EN 13612:2002, which is concise and does not contain extensive details. Additionally, there are three IMDRF […]
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The Performance Evaluation Plan outlines the resources and procedures for assessing the IVD’s performance. A separate standard exists for this: EN 13612:2002. It is brief and doesn’t provide extensive detail. You can generally grasp its contents by reviewing the table
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ISO 27001:2023 Section Document Section 4.3 Determining the scope of the information security management system 1. 4.4 Information security management system (All) 5.1 Leadership and commitment 8. 5.2 Policy 2. 5.3 Organizational roles, responsibilities, and authorities 8. Overview This document
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ISO 27001:2023 Section Document Section 6.1.1 Actions to address risks and opportunities – General 1., 2., 3. 6.1.2 Information security risk assessment 2. 6.1.3 Information security risk treatment 3. Overview This document outlines the methodology for identifying and managing information
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The following table links each section of ISO 27001:2023 to the relevant documents that fulfill these requirements. Section Title Fulfilled in Document 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties 4.3 Determining
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The Risk Management Report summarizes the outcomes of risk management activities. While the Risk Management Plan details the planning and methodologies, the actual risks are documented and examined in the Risk Table. The risk analysis process and its phases are
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This table aligns the sections of ISO 14971:2019 with the corresponding documents. The document titles in the “Fulfilled in Document” column reflect the FdaToday templates. Your system for naming documents might differ, so adjustments can be made as needed. ISO
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ISO 14971:2019 Section Document Section 5.2 (all; entries related to reasonably foreseeable misuse) 5.4 3 5.5 3, 4 6 3 7.1 4 7.2 4 7.3 4 7.5 4 IEC 62366-1:2015 Section Title Document Section 4.1.2 Risk Control as it relates
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1. Preliminary Remarks This document was prepared by the German Notified Bodies Alliance (“Interessengemeinschaft der Benannten Stellen für Medizinprodukte in Deutschland”, IG-NB) as a guide for Notified Bodies, manufacturers, and other interested parties. It is not intended to be comprehensive
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The Risk Management Plan outlines the risk policy and sets the criteria for risk acceptability. It also references relevant processes and activities integral to product-specific risk management within the integrated software development workflow (as detailed in SOP Integrated Software Development).
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