Implemented MDR requirements
The new European Medical Device Regulation (MDR) will go into effect in May 2020. It is intended to both increase product safety and further harmonize industry regulations. As a leading supplier of breast pumps, breastfeeding accessories and medical vacuum technology, Medela recognized the need to update its quality management processes and the technical documentation for each of its individual products. Together with UNITY, Medela planned and implemented this project in a structured manner, and at the same time, used the opportunity to take its business efficiency to the next level. In order to accomplish this, the entire process landscape was redesigned. MDR-relevant processes were tackled directly. Furthermore, UNITY analyzed the Medela product portfolio – both in terms of regulatory status as well as with regard to future business relevance. Based on this, Medela can make the right strategic decisions. With their extensive technical expertise, UNITY consultants also supported Medela in complying with the MDR through technical documentation as well as revising its standard operating procedures.
“I am impressed with the way the UNITY team works. They are not just another consulting company trying to roll out standard processes. They consider the entire project from a systemic perspective and guide everyone involved through the change process right from the start. UNITY also coached our employees to develop the best processes for the company.”
Thomas Ertl, Chief Operating Officer, Medela AG
Implemented Medical Device Regulation (MDR) requirements
Improved and simplified business processes
Company-wide roles and a governance concept
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Medical technology competence
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