ConvaTec Limited

Post Market Surveillance is performed in compliance with the EU regulations (Article 10(10). Clinical Evaluations and PMCF

Delegate PRRC for Gary Barrett. Conformity of Medical Devices is checked in accordance with the QM system (before delivery) (Article 10(9)) Technical Documentation is kept up to date (Article 10(4)+(6)) 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.

Delegate PRRC for Pamela Meadows Post Market Surveillance is performed in compliance with the EU regulations (Article 10(10). PMS Plans and Reports

Conformity of Medical Devices is checked in accordance with the QM system (before delivery) (Article 10(9)) Technical Documentation is kept up to date (Article 10(4)+(6)) 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.

Post Market Surveillance is performed in compliance with the EU regulations (Article 10(10). PMS Plans and Reports

Delegate PRRC for Dr Beate Painter-Hanson Post Market Surveillance is performed in compliance with the EU regulations (Article 10(10). Clinical Evaluations and PMCF