Primer Design Ltd

Head of QARA & Clinical Affairs All Novacyt companies (incl. Primer Design Ltd) Responsibilities reflect all those indicated in EU IVDR Article 15 (items 1-5), including but not limited to ensuring: Conformity of the devices is checked in accordance with the QMS prior to release. Technical documentation & DoC are drawn up and kept up to date. PMS obligations are complied with, per Article 10(9). Reporting obligations are fulfilled per Articles 82-86 inclusive. [IVDR pp201-202 for full list]