Codialist
Codialist GmbH is a medical device software development company that specializes in creating innovative, safe, and compliant software solutions for medical devices. With a strong focus on lifecycle management, safety, security, interoperability, and control algorithms, they support clients in bringing life-sustaining products to market. As a spin-off of Berlin Heart, they leverage extensive experience in medical technology to help improve patient care through advanced software engineering.
Industries
Nr. of Employees
small (1-50)
Products
Software system for mobile drive for ventricular assist device
Development of continuous pump and alarm functions, data logging and an integrated user interface for a mobile drive system used with ventricular assist pumps; included control-algorithm design, functional-safety measures and regulatory documentation to support CE/FDA approvals.
Control concept for implantable blood pump
Feasibility studies, physical modelling, identification experiments and closed-loop simulations to develop position and speed control, and flow estimation algorithms for an implantable blood pump with emphasis on reliability and low power consumption.
Algorithms for ECG evaluation
Development of signal-processing pipelines and algorithms for multi-channel ECG live display, measurement of waves and intervals, heart-rate computation and atrial fibrillation detection, verified using public and proprietary ECG reference databases.
Cloud connection functional model for medical devices
Technology selection, mapping of device data to FHIR, development of authorization concepts, and implementation of a functional IoMT data pipeline and prototype using cloud healthcare services and interoperability standards.
IT security analysis for connected/home-use product
Comprehensive IT security risk assessment including asset identification, threat-risk analysis, incident scenario definition and recommendations for secure update mechanisms and mitigations aligned with IEC 81001-5-1 and FDA guidance.
Legacy software gap analysis and remediation
Risk-based gap analysis and justification for continued use of legacy software in medical devices, using IEC 62304 legacy provisions and focused verification of hazardous scenarios rather than full redesign where appropriate.
Software system for mobile drive for ventricular assist device
Development of continuous pump and alarm functions, data logging and an integrated user interface for a mobile drive system used with ventricular assist pumps; included control-algorithm design, functional-safety measures and regulatory documentation to support CE/FDA approvals.
Control concept for implantable blood pump
Feasibility studies, physical modelling, identification experiments and closed-loop simulations to develop position and speed control, and flow estimation algorithms for an implantable blood pump with emphasis on reliability and low power consumption.
Algorithms for ECG evaluation
Development of signal-processing pipelines and algorithms for multi-channel ECG live display, measurement of waves and intervals, heart-rate computation and atrial fibrillation detection, verified using public and proprietary ECG reference databases.
Cloud connection functional model for medical devices
Technology selection, mapping of device data to FHIR, development of authorization concepts, and implementation of a functional IoMT data pipeline and prototype using cloud healthcare services and interoperability standards.
IT security analysis for connected/home-use product
Comprehensive IT security risk assessment including asset identification, threat-risk analysis, incident scenario definition and recommendations for secure update mechanisms and mitigations aligned with IEC 81001-5-1 and FDA guidance.
Legacy software gap analysis and remediation
Risk-based gap analysis and justification for continued use of legacy software in medical devices, using IEC 62304 legacy provisions and focused verification of hazardous scenarios rather than full redesign where appropriate.
Services
Medical device software development
Contract development of embedded and connected software for medical devices, including interface definition, integration with hardware partners, and delivery of development artefacts.
Lifecycle management and maintenance
Ongoing maintenance, vulnerability monitoring and implementation of software changes to ensure continued security, safety and regulatory compliance.
Systems development (mechatronic and app integration)
Integrated system engineering combining software with electromechanical components and user interfaces, coordinating partner capabilities for complete product solutions.
Regulatory and technical consulting
Advisory services on normative requirements, technology choices, risk management and regulatory strategies including preparation of submission documentation and early engagement with notified bodies/regulators.
Security analysis and threat modelling
Identification of IT security risks for connected and home-use devices, threat modelling, definition of security controls and secure update mechanisms aligned with IEC 81001-5-1 and relevant guidance.
Medical device software development
Contract development of embedded and connected software for medical devices, including interface definition, integration with hardware partners, and delivery of development artefacts.
Lifecycle management and maintenance
Ongoing maintenance, vulnerability monitoring and implementation of software changes to ensure continued security, safety and regulatory compliance.
Systems development (mechatronic and app integration)
Integrated system engineering combining software with electromechanical components and user interfaces, coordinating partner capabilities for complete product solutions.
Regulatory and technical consulting
Advisory services on normative requirements, technology choices, risk management and regulatory strategies including preparation of submission documentation and early engagement with notified bodies/regulators.
Security analysis and threat modelling
Identification of IT security risks for connected and home-use devices, threat modelling, definition of security controls and secure update mechanisms aligned with IEC 81001-5-1 and relevant guidance.
Expertise Areas
- Medical device software engineering
- Functional safety and risk management
- Cybersecurity for medical devices
- Control systems and biosignal algorithms
Key Technologies
- Model-based control and system identification
- Observers and Kalman filters
- Biosignal processing (ECG) and arrhythmia detection
- HL7 FHIR and SMART on FHIR