- 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.
Masqué
MILKAU Bastian
- 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.