Hill-Rom, Inc.

(1) Ensuring conformity of the device is appropriately checked in accordance with the Quality Management System (QMS) before the device is released; (2) Ensuring Post-Market Surveillance (PMS) obligations are met (ref. Article 10 (10) of MDR); (3) Ensuring reporting obligations relating to vigilance are met (ref. Article 87 to 91 of MDR)

(1) Ensuring technical documentation and EU Declaration of Conformity (DoC) are drawn up and kept up to date; (2) Ensuring that the Declaration for investigational device(s) used in clinical trials conforms to General Safety and Performance Requirements (GSPR) apart from aspects covered by the clinical investigation and every precaution has been taken to protect the health and safety of the subject (ref. Annex XV Chapter II Section 4.1 of MDR)