GE Parallel Design, Inc.

Person(s) Responsible for Regulatory Compliance (PRRC) are responsible for supervision and control of: the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released; the post-market surveillance obligations are complied with in accordance with EU MDR Article 10(10); the reporting obligations referred to in EU MDR Articles 87 to 91 are fulfilled;