Officers and regulatory representatives of KARL STORZ SE & Co. KG
SCHMITZ Stephanie
at least:
- ensuring conformity assessment in an appropriate manner in accordance with the QMS under which the products are manufactured before a product is released
- the technical documentation and the EU declaration of conformity are
drawn up and kept up-to-date;
- in the case of investigational devices, the statement referred to in
Section 4.1 of Chapter II of Annex XV is issued.
Hidden
MÄNDER Christian
at least:
- Obligation to monitor compliance with the requirements set out in Article 10(10) after placing on the market
- Obligation to monitor compliance with the reporting requirements set out in Articles 87 to 91