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CriTech's proprietary Critical Software Development Process (CSP) provides a highly structured software development lifecycle that is optimized for smaller development teams commonly found in medical devices.

Our process is available for license by select customers. On large projects, the CSP becomes a part of the project's deliverables.

Critical Software Development Process Description

The Critical Software Development Process (CSP) is a process tailored to the development of safety critical software for medical devices. For a given software development project, CSP defines:

The activities that should be performed

The order in which activities should be performed

The people responsible for completion of the activities

The documentation that should be produced


CSP complies with the IEEE standards for the development of critical software, the ISO 9001 standards for software development, and IEC 62304, Medical device software -- Software life cycle processes. CSP is based on software industry best practices.

CSP covers all seven phases of a software project, as defined by the IEEE:

Concept

Requirements

Design

Implementation

Test

Installation and Checkout

Operations and Maintenance


For each phase of a software project, CSP defines activities in seven functional categories:

Project Management

Quality Assurance

Configuration Management

Verification and Validation

Engineering

Hazard Analysis

Operations

 

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Last modified: August 2009