Helping you resolve customer complaints
and manage product recalls



Our experienced team can provide the following services:

  • ¬†Liaise with your EU distributors and ensure they act in a timely manner
  • Act as EU coordination centre for medical device customer complaints
  • Provide you with details and inform EU competent authorities where appropriate
  • Ensure your distributors respond to their complaints in accordance with your instructions
  • Inform you within 24 hours when complaints relate to actual or potential patient harm, and discuss best course of action
  • If a complaint indicates product recall is advisable or required by the competent authorities, we would proceed with your approval
  • It would be our responsibility to inform the competent authorities of nature of incident leading to the recall and obtain their approval before taking action with your distributors
  • Coordinate entire medical device product recall process throughout EU member state

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