Software Verification & Validation for SaMD
The most important activities of the software development lifecycle process. This process makes sure all requirements are met before testing the product in the real world.
Software verification is the first part of the development process to provide evidence that all specified requirements have been met. It confirms that your design outputs meet design input requirements. Verification activities include system/software requirement testing, code reviews and document inspections.
Software validation refers to the subsequent activities which confirm that software meets user needs and satisfies the intended use. Validation includes various activities such as product requirement/user requirement testing, clinical evaluation, clinical investigations, analysis and document inspections.
Software Verification & Validation Best Practices
Align with internationally recognised standards.
Verification & validation (V&V) activities should be planned early in the design stage while developing requirement specifications for a product. This will ensure there is a clear alignment between V&V stages and the defined specifications.
Maintaining traceability throughout the design and development cycle of medical devices is crucial as it provides an overview of the link that exists between user needs, specifications, verification and validation.
Regulatory references and standards to keep in mind include EU MDR Annex II Section 6.1(b) which directly cites the requirement for a verification and validation process. For in vitro diagnostics, the parallel EU IVDR Annex II Section 6.4 outlines the same requirements. The FDA, in 21 CFR 802.3 goes as far as providing their own simple definitions for verification: “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled” and Validation “confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled”.
Case Study
How Hardian solves the problem.
Hardian Health helps clients to streamline the overall development and approval process by sharing, guiding, training and initiating developing fundamental verification and validation stages. This includes Software Development Planning, outlining Product Requirement Specifications, Software Requirement Specifications, building Traceability Matrices, Risk Management Plans, Software Verification and Validation Plans, all in the early design stages.
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