Diomed Developments Limited

Ensuring MD conformity is checked according to QMS requirements before batch release.

Meeting post-market surveillance (PMS) obligations in accordance with Art 10(10) & fulfilling serious incident reporting, trending and field safety corrective action reporting obligations in accordance with Art 87 to 91

In relation to investigational devices to be used in clinical investigations, issuing the statement that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject (section 4.1 of Chapter II of Annex XV)

Drawing up and keeping up to date Technical Documentation and EU Declarations of Conformity. In relation to investigational devices to be used in clinical investigations, issuing the statement that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject