MDR Compliance in a Record Time: Cross-Functional Teamwork Fuels Success at Serres

At Serres, we’ve had patient and healthcare personnel safety as a priority from the very beginning. Due to our strict quality standards and world class product quality, we were able to obtain Medical Device Regulation (MDR) certification in record time.

Why is MDR important?

Medical Device Regulation (MDR) certification is a set of regulatory requirements that ensure the safety and performance of medical devices in the European Union (EU).

“The objective has always been to safeguard the health of patients and healthcare professionals to the greatest possible extent, as well as to improve the safety and effectiveness of our solutions” – Riku Vakoniemi, QA/RA Specialist at Serres.

Our product failure rate is 1 in a million, making Serres a top performer in the market. Due to our 95,5% delivery assurance, our customers can always rest assured that their operations will run smoothly and without additional effort.

Passion for patient and healthcare personnel safety, drives our team to extraordinary results.

At Serres, we have taken a proactive approach to MDR compliance, and our cross-functional team has been working together to ensure that all aspects of the regulation were taken into consideration. Through this collaboration, we were able to achieve MDR compliance in record time.

As Marika Hiula, R&D Engineer from Serres puts it “Compliance with MDR was achieved through dedicated testing, documentation, and collaboration as a team”.

We operate in over 50 countries, and we are compliant with the regulations and quality requirements of each of those markets.