Our Critical Software Development Process

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


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