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
Contract development of embedded and connected software for medical devices, including interface definition, integration with hardware partners, and delivery of development artefacts.
Ongoing maintenance, vulnerability monitoring and implementation of software changes to ensure continued security, safety and regulatory compliance.
Integrated system engineering combining software with electromechanical components and user interfaces, coordinating partner capabilities for complete product solutions.
Advisory services on normative requirements, technology choices, risk management and regulatory strategies including preparation of submission documentation and early engagement with notified bodies/regulators.
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.
Contract development of embedded and connected software for medical devices, including interface definition, integration with hardware partners, and delivery of development artefacts.
Ongoing maintenance, vulnerability monitoring and implementation of software changes to ensure continued security, safety and regulatory compliance.
Integrated system engineering combining software with electromechanical components and user interfaces, coordinating partner capabilities for complete product solutions.
Advisory services on normative requirements, technology choices, risk management and regulatory strategies including preparation of submission documentation and early engagement with notified bodies/regulators.
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
News & Updates
Control Concept for Implantable Blood Pump
Development of a control system for an implantable blood pump, including position, speed control, and flow estimation.
Algorithms for ECG Evaluation
Development of algorithms for ECG signal processing, heart rate evaluation, and atrial fibrillation detection.
IT Security Analysis for Home Use Product
Risk assessment and security measures for a home-use medical device connected to a smartphone app.
Legacy Software »Ikus User Interface«
Retrospective conformity assessment and risk analysis of legacy software in a life-sustaining device.
Cloud Connection of a Medical Device
Development of a secure, standards-based data pipeline for remote monitoring of implantable devices.
Control Concept for Implantable Blood Pump
Development of a control system for an implantable blood pump, including position, speed control, and flow estimation.
Algorithms for ECG Evaluation
Development of algorithms for ECG signal processing, heart rate evaluation, and atrial fibrillation detection.
IT Security Analysis for Home Use Product
Risk assessment and security measures for a home-use medical device connected to a smartphone app.
Legacy Software »Ikus User Interface«
Retrospective conformity assessment and risk analysis of legacy software in a life-sustaining device.
Cloud Connection of a Medical Device
Development of a secure, standards-based data pipeline for remote monitoring of implantable devices.