Transitioning from MDD to MDR compliance touches on several different business processes within a medical device manufacturing company while at the same time imposing non-negotiable deadlines for submission of documentation.
Add to that the need for ramping up a variety of activities for a limited time, and you have the situation at the outset for Ambu A/S, global supplier of Anesthesia, Patient Monitoring & Endoscope Solutions.
Case Story
The Short Version
Challenge: Ambu A/S requested assistance for the MDR transition of nine product families within a period of two years without any interruption in product supply or impact on ongoing innovation activities.
Solution: MGS Design & Development handled project management and brought the required subject matter specialists into the project as needed to ensure the appropriate level of documentation. The first submissions were done six months before final deadline and after that, regular submissions made sure all products were ready in time.
Result: The timely submissions of device documentation included 18 STED files and ensured our client’s continued supply of anesthesia products and solutions to the European markets, contributing to the total 2021/2022 revenue of more than DKK 200 mill.
The road to MDR compliance – planning and staying on track
The update of the device documentation to be finalized two years into the future was planned by the project group with a strong focus on cross-functional coordination.
The project plan included careful prioritization of the products in order of importance and was executed with continuous attention on keeping the project on track.
The first products ready for MDR approval were submitted to the notified body in December 2021, and in the period up to July 2022, regular submissions made sure all products were ready in time for the final deadline.
During correspondence between notified body and internal regulatory affairs, MGS Design & Development’s quality management specialist coordinated with the subject matter experts at Ambu A/S to gather the necessary information for responding to the requests.
MDR transition accomplished: to the finish line and beyond
In the MDR transition project completed together with Ambu A/S, MGS Design & Development has mainly assisted with project management and subject matter expertise in the fields of quality management, design control, and test & verification.
The timely updates and submissions of device documentation included 18 STED files and ensured the continued supply of key products and solutions within Anesthesia to the European markets, contributing to the total 2021/2022 revenue of more than DKK 200 mill.
Testimonials
What People Say?
Our MDR submission projects were planned to run in parallel with our new product innovation activities – and we estimated a high workload to finish in time. MGS Design & Development has taken a leading role in some of our MDR projects, collaborating with Ambu employees across multiple sites, and have supplied Ambu A/S with the necessary competencies to finalize in time.”
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