(a) conformity check before product release; (b) drawn up and kept up-to-date of the technical documentation and the EU declaration of conformity; (c) post-market surveillance; (d) vigilance; (e) performance studies
(according IVDR Article 15, chapter 3)
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SCHERER Kay
(a) conformity check before product release; (b) drawn up and kept up-to-date of the technical documentation and the EU declaration of conformity; (c) post-market surveillance; (d) vigilance; (e) performance studies
(according IVDR Article 15, chapter 3)