SMTL will, when possible and necessary:

  • Examine the device in the laboratory
  • Test the device and unused samples
  • Gather further information from the user/reporter

We will then:

  • Write a report summarising our findings including comments from the user
  • Send a report to the manufacturer, the MHRA AIC, NWSSP Procurement, and the reporting organisation
  • Chase the manufacturer for a reply
  • Assess the quality of the reply and decide whether we can close the file
  • Contact manufacturers who have sent unstuitable responses
  • Copy the final response to the MHRA, NWSSP and the reporting organisation 

The information from this process is also used to help inform Procurement contracting processes for NHS Wales, as well as contributing to the wider UK medical device incident reporting process.

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