MDR approval for Gold Anchor

Purpose and goal:

Naslund Medical develops, produces, markets and sells the medical device Gold Anchor. The product is CE marked according to MDD. The company has already succeeded in commercializing the product in many of the most important international markets.

The purpose of the project was to contribute to MDR approval for Gold Anchor. The project thus contributes to the company being able to continue providing doctors and patients in the EU with the most clinically advantageous gold marker and to continued growth of the company´s sales within the EU. Expected results and effects:

With the support of external consultants, the company has identified and implemented the required updates to the company´s quality management system and technical file to meet new requirements according to the MDR. The project has thus contributed to skills enhancement in the company and enabled continued growth of the company´s sales within the EU.

Approach and implementation:

The work has been carried out in collaboration with externally hired consultants. Initially, a gap analysis was carried out against the requirements according to the MDR. An action plan was then drawn up with the activities required to achieve full compliance with the requirements of the MDR.

These activities were then carried out by the company´s employees with significant consultant support. The activities included adaptations of the company´s quality management system as well as updating the technical file for Gold Anchor, not least regarding the clinical evaluation.