Qureshi Manufacturing Corporation

The conformity of medical devices is checked in accordance with the QM system (before delivery) (Article 10(9)). The technical documentation is kept up to date (Article 10(4) and (6)). Market surveillance is performed in compliance with the EU regulations (Article 10(10)). The reporting obligations according to the EU regulations are met (Article 10(13)). For “investigational devices”, the statement according to Annex XV, Chapter 2 is issued.