Officers and regulatory representatives of Elygn GmbH
KHAN Abdul Hannan
Person Responsible for Regulatory Compliance (PRRC) under MDR Art. 15(3): ensuring (a) conformity checks before release, (b) technical documentation incl. Annex XIII custom-made statements are drawn up and kept up to date, (c) post-market surveillance is fulfilled, (d) incident/FSCA reporting obligations (Arts. 87–92) are met, and (e) investigational-device obligations where applicable.