


MDR Post Market Surveillance!!! To do list *ASAP
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update the benefit-risk determination and to improve the risk management,
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update the design and manufacturing information, the instructions for use and the labelling,
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update the clinical evaluation,
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update the summary of safety and clinical performance (if applicable),
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detect reportable trends,
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update the technical documentation,
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identify necessary preventive, corrective or field safety corrective action,
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identify opportunities to improve the usability, performance and safety of the device,
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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