Officers and regulatory representatives of Technomed Europe
HUURDEMAN Judith
Ensuring that:
• Technical documentation, EU DoC, and PMS (Art. 10(10), excl. complaints) are maintained.
• Reporting obligations (Arts. 87–91) are fulfilled.
• For investigational devices, the Annex XV chapter II section 4.1 statement is issued.
• Conformity is verified under the QMS (Art. 10(9)) before release.
• PMS obligations on complaint handling (Art. 10(10)) are met.