Dirigeants et représentants réglementaires de Seqstant GmbH
WRETTOS Georg
Fulfill reporting duties per Articles 87–91 [82, 86 IVDR] and issue statements for investigational devices per Annex XV [XIV IVDR]. Verify device conformity under the quality system before release. Maintain updated technical documentation and EU declaration. Comply with post-market surveillance per Article 10(10) [10(9) IVDR].