Medical Developments International Limited

- Ensuring that the post-market surveillance obligations are complied with in accordance with Article 10 (10); - Ensuring that the reporting obligations referred to in Articles 87 to 91 are fulfilled; - Ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued

- Ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up to date. - Ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

- Responsible for the control and management of all Quality activities associated with Regulatory Compliance. - Supplier Quality Assurance. - Internal audit program and inspection management for all MDI products and devices. - Specifications and Regulatory compliance. - Complaint handling. - Inspection Management - Monitor and tracking non-conformances

- Ensuring that the post-market surveillance obligations are complied with in accordance with Article 10 (10); - Ensuring that the reporting obligations referred to in Articles 87 to 91 are fulfilled; - Ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued