Proven Software Development Life Cycle
Our Critical Software Development Process
CriTech's proprietary Critical Software Development Process provides a set of highly structured software development life cycles optimized for development projects commonly found in medical devices. It is process-tailored to the development of safety-critical software. For a given software development project, our process defines:
- Activities to be Performed
- Order in Which These Activities are Performed
- Engineers Responsible for Completion of the Activities
- Documentation Produced
Compliance
Our process complies with the IEEE standards for the development of critical software, the ISO 13485 standards and IEC 62304 "Medical Device Software — Software Life Cycle Processes." It 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
Seven Functional Roles
For each phase of a software project, activities in seven functional roles are defined. These include:
- Cybersecurity Risk Management
- Software Development
- Project Management
- Software Risk Management
- Software Configuration Management
- Software Quality Assurance
- Verification