07/06/2024
Innoview GmbH is proud to announce its approval of the conformity of its Quality Management System in accordance with the European Regulation for Medical Devices (EU) 2017/745 (MDR). We have implemented all requirements in accordance with Annex IX, Chapter I. Art. 2,3, and Chapter III. of the Regulation (EU) 2017/745 (MDR) to comply with the essential safety and performance requirements as well as; have successfully passed the auditing process of our entire QM system.
Today we are MDR certified and have attained this certification for all our 10 product groups of Rigid Endoscopes. This means that we can serve you (our customers-(old and new)) better, and give you certainty and confidence in purchasing all our products. As the safety of patients is our priority, we made it a call to duty and a top priority to work towards ensuring that our products meet the required regulatory standards for safety and performance and today, that effort is a reality for all of us at Innoview GmbH.
Innoview GmbH not only stands for producing technically excellent and quality endoscopes which are manufactured by our in-house expertise and experienced employees, and are manufactured to the highest quality, but also for its robust and functional quality management system, which has been able to overcome the hurdles of the MDR approval process earlier than many of our competitors. This allows us to give our customers the certainty that we are efficient as we already comply with the complex rules of the MDR. This certificate is valid for all Rigid endoscopes of Innoview GmbH. Details of the devices covered can be found on the second and third pages of this certificate on our website .info.
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