Software as a Medical Device (SaMD) Development Procedure

The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes. The procedure provides instruction and guidance throughout the software lifecycle and establishes critical linkage to QMS and regulatory requirements.

• MS Word Format

• Digital Content - Instant Download

Software as a Medical Device (SaMD) Development Procedure

The SaMD Development Procedure governs the planning and realization of Software as a Medical Device (SaMD) product lifecycle processes.

SaMD Development Procedure Overview

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