Software as a Medical Device (SaMD) Development Procedure

Plan and control the lifecycle of Software as a Medical Device (SaMD) with this editable development procedure. It guides product definition, requirements, design, implementation, verification, release, configuration control, maintenance and risk-management records within a medical device quality system.

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Supplied as one editable Microsoft Word document in a digital download.

The Software as a Medical Device (SaMD) Procedure includes detailed guidance on the following:

• Product Planning and Categorization

• Risk Management

• Documentation requirements

• Configuration Management and Control

• SaMD Realization and Use

• Software Design

• Software Development

• Software Verification and Validation

• Software Deployment / Installation

• Software Maintenance

• Software Decommissioning

Software across its lifecycle

The SaMD Development Procedure moves from product planning and a software definition statement into requirements, design, implementation, verification and release activities. It assigns roles to software engineering, quality, management and external developers where applicable.

Controls and records

Risk management, design reviews, configuration management, traceability and the design history file accompany the development work. Maintenance and post-market feedback are part of the same lifecycle rather than a separate afterthought.

The revised procedure references IEC 62304:2006 including Amendment 1:2015 and the EU Medical Device Regulation (MDR), Regulation (EU) 2017/745.

Use the Software Development Plan to organize lifecycle activities, the Human Factors and Usability Engineering Procedure for user-interface risks, and the Software Clinical Evaluation Procedure for clinical evidence supporting SaMD claims.

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.

Software Development Plan vs SaMD Procedure vs Software Bundle