ISIT

ISIT – Compliance and security accelerator for critical embedded software

For more than 30 years, ISIT has been supporting robotics and medical device manufacturers in the design, security and certification of their high-stakes embedded software.

We combine expertise in operational safety, cybersecurity and regulatory compliance to help technical teams master the entire software lifecycle: from architecture to validation, to CE marking and FDA requirements.

Our added value lies in a offer combining:

• Regulatory support & certification
  Operational support for CE marking and FDA compliance, audits and assistance in the application of critical standards (IEC 62304, IEC 81001-5-1, etc.).
• Skills development of the teams
  Specialized training in functional security, cybersecurity, risk management and compliant software development (IEC 62304, ISO 81001-5-1, "Secure by Design", MISRA, etc.).
• Toolchain suitable for critical software
  Implementation of verification, requirements management and traceability tools compatible with regulated environments.
• Integration of certifiable technological building blocks
  CANopen Safety, EtherCAT, FSoE stacks and real-time solutions for secure and high-performance embedded architectures.

Thanks to this comprehensive approach, ISIT helps its clients design reliable, compliant and resilient products while reducing risks, securing audits and accelerating time to market.

Expertise, services & support

• Regulatory compliance consulting and certification (CE marking & medical standards)
• Cybersecurity and functional safety audits
• Risk analysis, quality processes and requirements management
• Outsourcing of software unit testing

Training & skills transfer

• Security and cybersecurity standards (IEC 62304, IEC 81001-5-1, MISRA, Secure by Design, etc.)
• Requirements and risk management
• Best practices in embedded development and risk management

Tools & platforms

• Tools that can be described as static analysis and software composition
  • SAST, DAST, SCA/SBOM, sound technologies for critical environments (V&V)
• Requirements management & traceability
  • Bidirectional traceability, risk management and compliance across the entire lifecycle
• Automated testing, validation, and verification suites
  • Unit and integration test suites, automation of verification campaigns, industrialization of validation processes

Technologies & Integration

• Supply and integration of CANopen Safety, EtherCAT, FSoE stacks…
• Embedded real-time solutions and secure industrial communication