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Risk Management


For 50+ years, LRE has utilized Risk Management processes that consistently achieve results superior to those achieved with other means in order to anticipate, record, communicate and control project and development risks.

LRE Medical establishes, documents and maintains throughout the lifecycle of a medical device an ongoing process for identifying hazards. Its’ processes provide for the continual estimation and evaluation of associated risks along with controlling the risks, and monitoring the effectiveness of its controls. LRE’s processes include the following elements:

  • Risk Analysis
  • Risk Evaluation
  • Risk Control
  • Review Residual Risk Acceptability
  • Risk Management Report
  • Production and Post-Production Information

A schematic representation of LRE’s Risk Management process is illustrated below:



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