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IDT seminar from Prof. Patrizio Pelliccione on: “Software certification: Lessons Learned from the Development of a Mechanical Ventilator for COVID-19”



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During the COVID-19 pandemic, around the middle of March 2020, a group of physicists, engineers, and physicians offered  their  time  and  competencies  to develop a simplified mechanical lung  ventilator,  called  MVM  (Mechanical  Ventilator  Milano),  to answer  the  high  request  of  ventilators  for  Acute  Respiratory Distress  Syndrome  (ARDS)  in  intensive  care  units.  A  prototype was  ready  in  around  one  month. Since  medical  software  malfunctions  can  lead  to  injuries  or death  of  patients,  before  marketing  MVM  ventilators  and  distributing  them  in  hospitals,  software  certification  in  accordance with   the   IEC   62304   standard   was   mandatory   to   guarantee system reliability. The team was then complemented by computer scientists   specifically   devoted   to   this   task.   The   software   re-engineering  process,  which  lasted  around  two  months  from  the end of the prototype, brought to a strong re-implementation of the device software components, which involved all the stakeholders in  a  continuous  integration  setting. In this talk, I will report the experience of the MVM control SW re-engineering  necessary  to  show  evidence  that  the  SW  adheres to the standards and to consequently obtain the certification. I will share results and lessons learned from this social project, where more  than  100  volunteer  researchers  worked  towards  software certification at the extreme of their strength to get a real device finished  in  a  rush  since  strongly  required  to  support  physicians in  treating  COVID-19  patients.