System Development
System development at Critical Software focuses on delivering robust, compliant, and scalable architectures for medical and pharmaceutical applications.
We support the full lifecycle — from concept and requirements definition to integration, validation, and certification.
Requirements Engineering
We define and manage system-level requirements with full traceability, ensuring alignment with stakeholder needs and regulatory constraints. Our process includes stakeholder analysis, risk identification, and configuration management, helping teams avoid costly rework and delays.
Architecture & Specification
Using Model-Based Systems Engineering (MBSE), we model and validate system architectures, define sub-system interfaces, and optimize performance across domains. Our work complies with ISO 15288 and IEC 60601, ensuring that the systems are safe, interoperable, and future-ready.
Integration & Validation
We support the integration of hardware, software, and communication layers, ensuring seamless operation and compliance with standards like ISO 14971 and IEC 62304. Our teams apply both Agile and V-Model approaches, tailoring the methodology to project needs.
Legacy System Evolution
We help clients modernize outdated systems through gap analysis, reverse engineering, and re-design. This includes updating documentation, improving performance, and ensuring compliance with current safety and regulatory standards.
Digital Engineering & Simulation
We use digital twins, simulation environments, and predictive analytics to validate system behavior before deployment. This reduces risk, improves efficiency, and accelerates time-to-market.
Certification Support
Our system development services include full documentation and traceability to support audits and certification processes. We help clients prepare technical files, risk management reports, and validation evidence aligned with MDR, FDA, and other global regulations.
