Software Clinical Evaluation Procedure
Evaluate the clinical evidence supporting Software as a Medical Device (SaMD) claims with this editable Software Clinical Evaluation Procedure. It guides planning, responsibilities, evidence assessment and review across valid clinical association, analytical validation and clinical validation, with ongoing consideration of post-market performance.
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Supplied as one editable Microsoft Word document in a digital download.
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a SaMD in order to generate clinical evidence verifying the clinical association and the performance metrics of software when used as intended. The Software Clinical Evaluation Procedure provides guidance on three distinct aspects: (1) Valid Clinical Association; (2) Analytical Validation, and (3) Clinical Validation activities. The procedure includes definition of responsibilities, evaluation process flow and methods of generating and assessing relevant evidence used in each area of clinical evaluation.
Evidence for SaMD claims
The software clinical evaluation process begins with a SaMD definition statement and the clinical claim it is intended to support. It considers valid clinical association, analytical validation and clinical validation as distinct parts of the evidence package.
Review and learning
The document calls for independent review of the evaluation and continued assessment of post-market performance data. New evidence can change the clinical conclusions or prompt updates to the software and its supporting documentation.
The revised procedure references IEC 62304:2006 including Amendment 1:2015 and the EU Medical Device Regulation (MDR), Regulation (EU) 2017/745.
Related documents for this workflow
Plan the software lifecycle activities that generate supporting records. Medical Device Software Development Plan.
Review the broader medical device clinical evaluation process. Clinical Evaluation Procedure.
Connect clinical evidence to the software development lifecycle. SaMD Development Procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Medical Device Software: Development, Validation and Clinical Evidence for workflow guidance, a checklist and common mistakes.
Part of a procedure bundle
This document is also included in Medical Device Software Procedure Bundle. Explore the bundle for the related documents.
