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​MDR Post Market Surveillance!!!           To do list​ *ASAP

  1. update the benefit-risk determination and to improve the risk management,

  2. update the design and manufacturing information, the instructions for use and the labelling,

  3. update the clinical evaluation,

  4. update the summary of safety and clinical performance (if applicable),

  5. detect reportable trends,

  6. update the technical documentation,

  7. identify necessary preventive, corrective or field safety corrective action,

  8. identify opportunities to improve the usability, performance and safety of the device,

  9. if applicable, to contribute to the post-market surveillance of other devices,

                     TO BE CONTINUED... BRAINSTORM!

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We advise from classification to post market surveillance