Officers and regulatory representatives of ATI Labs sp. z o.o.
MITURA-WEŁNOWSKA Martyna
All points below, under Regulation (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, require the person responsible for regulatory compliance to:
a) Verify product compliance with the quality system before release.
b) Maintain technical documentation and EU Declaration of Conformity.
c) Adhere to post-market surveillance obligations (Article 10(10)).
d) Fulfill reporting duties (Articles 87-91).
e) Issue a statement for tested products (Annex XV, Chapter II, Section 4.1).