ReWing s.r.l.

She is responsible for ensuring the presence of a signed declaration for the device under investigation specifying that the device in question complies with the general safety and performance requirements with the exception of those aspects that are the subject of the clinical investigation and that, for the latter, all precautions have been taken to (in accordance with Annex XV, Chapter II, point 4.1.)

He is responsible for ensuring that the conformity of the device is adequately controlled in accordance with the quality management system; writing and updating the technical documentation and the EU Declaration of Conformity; responsible for the post-market surveillance (in accordance with Article 10, paragraph 10) and for the reporting (in accordance with articles from 87 to 91).