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Medical Devices

Altran provides end-to-end Medical Devices product innovation and development. Projects have been delivered to meet FDA and EEC regulatory requirements.

Specific offers include:

  • Systems Engineering. Packaged offers to develop medical device products and improve lifecycle performance, including Requirements Based Systems Engineering, Model Based Systems Engineering and Innovative Design (to X) which incorporates proprietary eXtreme Systems Engineering techniques (XSA/XSE).
    Example projects include:
    • Production of system requirements and design for the first wireless digital X-ray detector, using XSA/XSE techniques
    • Re-design based on identification of cost-improvements of a compact, intelligent UV-based decontamination system (embedding multiple safety-related functions and multiple technologies)
    • Systems Engineering consulting including delivery of a functional analysis and concept definition as part of a consortium developing a remote patient monitoring system
  • aSSureD Safety Systems Development: a packaged offer for the design, implementation and assurance of medical devices systems to meet medical safety standards including IEC 60601 and IEC 62304. Offer includes hardware, software and hardware/software integration. 
    Example projects are:
    • Development of a safety-related dynamic motion management system for a nuclear imaging body scanner
    • IV&V of critical software controlling radiotherapy treatment
    • Development and prototype delivery of a board controlling a dental surgical instruments robot. The board was based on an ARM 7 core for motor control & monitoring, and operated from a PC via an RS232 link
    • Software and hardware design reviews of a vital signs monitor against IEC 60601, also advising where software production methods could be strengthened
  • Advanced User Experience : a packaged offer providing advanced HMI technology experience and proprietary frameworks and IP for improving human interactions with medical devices and systems.
    Example projects are: 
    • Prototyping of a hand-held solution to train medical professionals to an acceptable standard within the tightened budgets of teaching hospitals. The prototype incorporated a 3D virtual reality environment, real-world physical interaction and detection of gestures and positioning
    • Development of the new HMI for a hemodialysis machine
  • Safety: End-to-end safety engineering (including safety case development) and Independent Safety Assessment for medical devices, to ISO 14971.
    Example projects include: 
    • Risk assessment of an ultrasonic medical implant system to ISO 14971
    • HAZOP studies to identify safety requirements for a Syringe driver & stack and an Infusion Pump
  • Connectivity. Intelligent Systems / Altran cross-fertilises connectivity expertise from other industry sectors for medical devices applications.
    Examples include:
    • Development of a demonstrator to transfer ECG data from a bio-sensor to an iPhone, via WiFi
    • Design of a connectivity framework for connecting the following systems while maintaining overall system integrity: client & competitor medical devices, European clinical information systems, blood pressure monitors, medical scales, clinics & hospitals, services & applications

 

 

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