SECU FIM software

Project

Development of on-board software to control the CARMAT cardiac prosthesis in degraded mode (SECU) for the first implantation in humans (FIM)

#Embedded software #C language #Texas Instrument DSP #IBM Rational DOORS #IBM Rational Rhapsody #IBM Rational Test Real Time

Challenges & objectives

The CARMAT prosthesis replaces the ventricles of the patient’s heart. It must be capable of autonomously controlling the blood flow of two ventricles in order to maintain a stable heart rhythm, adapted to the patient’s morphology and activity, whatever his position.

SECU software = control of the CARMAT cardiac prosthesis in degraded conditions.

Objective: first implantation in humans (First In Men)

Requirements

EN ISO 13485 / 62304 / 62366 / 14971

Compliance with customer document repository

Complete requirements traceability in Doors

Software specification

UML design in Rhapsody

Prosthesis SECU software implementation

Unit, integration and validation testing under RTRT

High level of testing (100% MCDC TU coverage…)

Our achievements

Each project reflects our ability to transform a critical requirement into a concrete solution. From the embedded software layer to functional safety, Médiane Système mobilizes all its expertise to deliver innovative, robust solutions ready for industrialization.