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Testing and validation of an artificial heart system 

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Context and objectives

Within the “system and software” business unit, MCA was in charge of the software’s IVVQ tasks for all components of the artificial heart system.

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Achievements/Tasks

  • Impact analysis of new or modified requirements.
  • Designing the Verification strategy, plans and objectives of Controller, CSH (Hospital Care Console) and Prosthesis software.
  • Designing the Validation strategy, plans and objectives of Controller, CSH (Hospital Care Console) and Prosthesis sub-systems and system.
  • Specification of system and software test procedures.
  • Implementation of automatic test procedures in RTRT.
  • Carrying out data prediction models in Excel.
  • Running TU, TI, TV, TA campaigns on all system components.
  • Hardware/software integration and bench testing (oscilloscope, multimeter, laboratory tools, etc.).
  • Management of technical data (bugs, request for changes etc.).
  • Implementation of all modules and traceability requirements in DOORS.
  • Software tools: Excel, Labview, DOORS, Change, Synergy, PLM teamCenter
  • Language: Vba-Excel, G, C, RTRT
  • Test file delivered for a feasible clinical trial configuration to be accepted (on patients).

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Deliverables/Results

Test file delivered for a feasible clinical trial configuration to be accepted (on patients)

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