MDR compliance at Stille

Purpose and goal

The purpose of the project is to provide Stille with sufficient regulatory competence within the new Medical Devices Regulation, MDR, in order to successfully adapt both existing as well as new products to the new requirements. The objectives with the project are to train the staff in the new requirements, develop methods according to the updated risk management procedures and to generate all necessary documentation for all instruments and OTs so that they all meet the requirements in the MDR and is ready for inspection from a notified body. The purpose and objectives were fulfilled.

Expected results and effects

The external competence was important in order to conduce Stille a deepened knowledge within quality and regulatory in accordance with MDR, which is a prerequisite for the future business. The long term benefits lied within that the acquired knowledge enabled continued development of innovative high tech medical devices. The project supported the company’s development and commercialization of a new innovation within MedTech and increased our ability to continue our prosperous development as a market leader in the global market. The reached results were satisfying.

Planned approach and implementation

The project consisted of one work package WP1 Regulatory conformity towards MDR. The project lasted from February 2019 to November 2019 and kept the scheduled time plan and met the expected results.