Consulting Services

We identify and mitigate potential hazards early in the development cycle, ensuring your device meets ISO 14971 standards and lays the foundation for safer, more reliable products.

We translate clinical and user needs into clear, testable system requirements—ensuring alignment between stakeholders, developers, and regulators from the start.

We support ongoing compliance through proactive monitoring, analysis, and corrective actions—ensuring your device stays safe and effective in real-world use.

Our engineers assess device security risks and develop mitigation strategies to meet evolving cybersecurity requirements and protect patient safety and data.

We create robust verification plans and automated testing strategies that streamline validation, improve traceability, and reduce costly manual errors.

Our team develops compliant Standard Operating Procedures tailored to your organization, supporting consistent quality management across hardware, software, and risk processes.

We design with the user in mind—applying human factors engineering to reduce use errors, enhance the user experience, and align with global regulatory expectations.