SaaMD Design History File (DHF)
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A SaaMD Design History File (DHF) is a DHF for a Software as a Medical Device.
- Context:
- It can (typically) be a Technical System-Software Document.
- It can contain:
- Software Development Plan (SDP) - A document that outlines the approach, methods, and resources to be used for software development.
- Product Safety Risk Management Plan (PSRMP) - A plan that identifies, assesses, and mitigates potential safety risks associated with a product.
- Product Risk Management Plan (PRMP) - A plan that identifies, assesses, and mitigates potential risks associated with a product.
- Software Configuration Management Plan (SCMP) - A plan that outlines the processes and procedures for managing software configuration changes.
- Product Requirements Specification (PRS) - A document that describes the functional and non-functional requirements of a product.
- Requirements Phase Exit Review Report (PERR-R) - A report that documents the findings and outcomes of a review conducted at the end of the requirements phase of a project.
- Software Requirements Specification (SRS) - A document that describes the detailed functional and non-functional requirements of a software system.
- Validation Plan (VaP) - A document that outlines the approach and methods for validating that a product meets its specified requirements.
- Software Verification Plan (SVeP) - A plan that outlines the approach and methods for verifying that a software system meets its specified requirements.
- Design Phase Exit Review Report (PERR-D) - A report that documents the findings and outcomes of a review conducted at the end of the design phase of a project.
- Product Risk Analysis Report (PRAR) - A report that identifies and assesses the potential risks associated with a product and proposes mitigation strategies.
- Product Safety Risk Analysis Report (PSRAR) - A report that identifies and assesses the potential safety risks associated with a product and proposes mitigation strategies.
- Verification Protocol (VePr) - A document that specifies the test procedures to be used for verifying that a software system meets its specified requirements.
- Verification Test Record (VeTR) - A record of the results of the tests performed during the verification phase of a software development project.
- Master Traceability Analysis (MTA) - A document that traces the requirements, design, and test artifacts to ensure that all requirements have been met and tested.
- Verification Summary Report (VeSR) - A report that summarizes the results of the verification phase of a software development project.
- Open Anomalies Report (OAR) - A report that documents any outstanding issues or defects identified during the testing and verification phases of a software development project.
- Software Release Note (SRN) - A document that provides information about the changes and updates included in a software release.
- Product Deployment Plan (PDP) - A plan that outlines the approach and methods for deploying a product to the intended users or customers.
- Validation Phase Exit Review Report (PERR-V) - A report that documents the findings and outcomes of a review conducted at the end of the validation phase of a project.
- ...
- See: Technical Software-System Document.