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Our Critical Software Development Process

CriTech's proprietary Critical Software Development Process (CSP) provides a set of highly structured software development life cycles optimized for development projects commonly found in medical devices. The CSP is process-tailored to the development of safety-critical software. For a given software development project, CSP defines:

• Activities to be Performed
• Order in Which These Activities are Performed
• Engineers Responsible for Completion of the Activities
• Documentation Produced

CSP Compliance

CSP complies with the IEEE standards for the development of critical software, the ISO 9001 and ISO 13485 standards, and IEC 62304 "Medical Device Software — Software Life Cycle Processes." CSP is based on software industry best practices and covers all phases of a software project, as defined by the IEEE, including:

• Concept
• Requirements
• Design
• Implementation
• Test
• Installation & Checkout

Six Functional Roles

For each phase of a software project, CSP defines activities in six functional roles. These include:

• Verification and Validation
• Technical Engineering
• Software Safety Engineering
• Project Management
• Quality Assurance
• Configuration Management

We specialize in software verification and validation for medical devices.