Safeshield India Rubber Products Pvt. Ltd.

Manager Regulatory Affairs: The responsibility relates to the completion of all documents 1) conformity of medical devices is checked in accordance with the QM system (Article 10(9)). 2)Technical documentation is kept up to date (Article 10(4) and (6)). 3) Market surveillance is performed in compliance with the EU regulations (Article 10(10)). 4) The reporting obligations according to the EU regulations are met (Article 10(13)).