In a recent project, we defined and implemented a strategy to develop a coherent system across all devices manufactured by our customer, to make their Risk Management System a living process. The objective of our customer was to be able to update regularly their Risk Management by evaluating the impact of information from the production phase and Post Market Surveillance (PMS) system.

Starting with the update of the Risk Management SOP and the transfer of all risk analysis matrices into identical formats, we were able to help them identify key elements for an easier implementation of PMS data.

We developed together the right tools, such as Initial Hazard Analysis, Fault Tree Analysis and Failure Mode and Effect Analysis to assess the risks related to design, use / application, process and software. We also provided our customer with an ISO 14971 training, to ensure optimal ownership of the process.

For the manufacturer, it is necessary to eliminate or reduce risks as far as possible through safe design and manufacture. Therefore, we assist our Clients through all phases of Risk Management including:

  • Creation of an SOP,
  • Development of the risk management file,
  • Risk analysis, including software risk analysis compliant with IEC 62304 and “Use” risk analysis aligned with IEC 62366
  • Risk assessment,
  • Risk evaluation,
  • Risk control,
  • Verification of efficacy, and
  • Implementation of feedback from PMS,

during all life-cycle phases of the medical device including:

  • development,
  • production,
  • verification and validation, and
  • post-market.