CODIALIST offers specialized embedded software development for medical devices, focusing on functional safety, cybersecurity, and regulatory compliance. They create robust software solutions for critical medical applications, ensuring adherence to global market approval standards.
Funding
Funding not disclosed
Founders
Product
Problem
Developing embedded software for medical devices presents significant challenges in ensuring safety, security, and regulatory compliance. The complex interplay of hardware, software, and stringent healthcare standards requires specialized expertise to prevent patient harm and facilitate market access.
Solution
CODIALIST provides specialized embedded software development services for medical devices, leveraging extensive experience from life-sustaining product development. The company focuses on creating robust software solutions that enhance patient care and improve quality of life across critical medical fields. Their approach integrates functional safety, cybersecurity, and interoperability from the initial design phase, ensuring adherence to regulatory documentation requirements for global market approval. CODIALIST collaborates closely with clients to deliver tailored software that meets specific device functionalities and therapeutic or diagnostic objectives.
Target Audience
The primary customers are medical device manufacturers and original equipment manufacturers (OEMs) seeking expert embedded software development and regulatory compliance support for their products.
Features
- Embedded software development for medical devices, including intensive care, cardiology, and surgery applications.
- Implementation of functional safety measures compliant with standards such as IEC 60601 and IEC 61508, incorporating risk management processes aligned with ISO 14971.
- Cybersecurity development adhering to standards like IEC 81001-5-1 and FDA guidance, including threat modeling, security testing, and Software Bill of Materials (SBOM) management.
- Design and implementation of control and algorithms for therapeutic and diagnostic functions, including biosignal measurement, evaluation, and real-time system control.
- Development of interoperability solutions utilizing medical technology standards like HL7 FHIR for seamless integration with other devices and clinical workflows.
- Generation of comprehensive technical documentation required for regulatory submissions and market access.
- Software lifecycle management, including maintenance, vulnerability monitoring, and updates to ensure continued compliance and performance.
- "In-the-loop" hardware testing and automated test suites for enhanced software verification and validation.