Development of an Intraoperative Indicator of Pancreatic Leakage to Reduce Postoperative Pancreatic Fistula

Purpose and goal

The aim of the project was to strengthen our expertise in the regulatory field and the work required to get a product CE-marked. The goal was that, with the help of a regulatory expert, plan and carry out biocompatibility studies, writing, editing and collecting the technical documentation required for a complete technical file as well as to initiate contact and set up a schedule with a notified body for the CE marking of our product.

Expected results and effects

We have performed the biocompatibility tests we planned and are now a year later ready to submit the technical file to our notified body within a couple of weeks. We feel well prepared and expect the review of our technical documentation to be accepted. In addition, the project has served as a practical example of educating our company in the regulatory process and helped us to further develop our working methods.

Planned approach and implementation

The competence enhancement has been through hiring of a consultant who is an expert in the regulatory area with a contact network of additional experts. The work has been done in the form of regular telephone meetings, a number of longer meetings when the regulatory consultant has come to us for joint work on site and review of technical documents and plans. To be able to push the project forward quickly, it has been very valuable to have the expertise at hand.