Surfix BV

1) Checking conformity of the medical device in accordance with ISO 13485 quality management system. 2) Drawing up and updating the technical documentation and the EU declaration of conformity. 3) Complying with post-market surveillance activities. 4) Ensuring vigilance reporting, trend reporting, and reporting for field safety corrective actions. NB: Full responsibility for the above will be effective from 1st September 2022.

Providing support to the following activities: 1) Checking conformity of the medical device in accordance with ISO 13485 quality management system. 2) Drawing up and updating the technical documentation. NB: Responsibility as a person responsible for regulatory compliance will be relinquished from1st September 2022.