Medovate Limited

Ensures that Medovate establishes, documents, implements, maintains, keeps up to date and continually improves the quality management system that ensures compliance with the Medical Device Regulation 2017/745 Ensures that the devices being released from routine manufacturing have been manufactured in accordance with the appropriate QMS documentation and that quality control (QC) release criteria are traceable to the device specification

Investigational Devices - ensures that a signed statement is issued (in line with Section 4.1 of Chapter II of Annex XV, Section 4.1, MDR ) to declare the device conforms to the GSPR`s apart from the aspects covered by the clinical investigation and that, about those aspects, every precaution has been taken to protect the health and safety of the subject. Oversight of project design and development technical documentation that supports the provision of conformity assessment evidence

Shall check that each item of technical documentation has been drawn up and kept up-to-date according to the Article 10(4) of (EU) 2017/745 MDR, Ensure the EU Declaration of Conformity has been signed and kept up to date according to Article 10(6) of the (EU) 2017/745 MDR. Ensure PMS surveillance obligations are complied as per Article 10(10),EU MDR including PMCF activities. Shall be fully involved in every aspect of Article 87 to Article 91 of (EU) 2017/745 MDR.