- Checking device conformity, in accordance with the quality management system before a device is released [MDR Art 15(3)(a)]
- Ensuring that post-market surveillance obligations are complied with in accordance with Article 10(10) [MDR Art 15(3)(c)]
- Ensuring that reporting obligations referred to in Articles 87-91 are fulfilled [MDR Art 15(3)(d)]
- In the case of investigational devices, issuing the statement referred to in Section 4.1 of Chapter II of Annex II [MDR Art 15(3)(e)]
Masqué
NELSON Zachary
- Ensuring technical documentation is drawn up and kept up to date [EU MDR Art 15(3)(b)]
- Ensuring declaration of conformity is drawn up and kept up to date [MDR Art 15(3)(b)]