News
MDR certification for MEDISEPT products!
We are proud to announce that we have obtained the MDR certificate—a certificate covering medical devices manufactured by MEDISEPT!
We are delighted to announce that on November 27, 2024, we obtained the EU Quality Management System Certificate in accordance with 2017/745 Annex IX Chapters I, III (MDR) / acc. 2017/745 Annex IX Chapters I, III (MDR) for Class IIa and IIb devices, i.e., our products for cleaning and disinfecting medical devices.
It was a lengthy process, which is why we are particularly proud that, as one of the first manufacturers of disinfection products in Europe, we have implemented a quality management system for medical devices and hold certification in accordance with the stringent requirements of the MDR!
What does this mean for us?
We have undergone a series of complex, demanding audits related to the ISO 13485 system, technical documentation, and additional documents verified by a notified body. Our products meet the highest quality standards, which enhance the requirements for the manufacture of medical devices, as well as their safety and effectiveness.
We have undergone a series of complex, demanding audits related to the ISO 13485 system, technical documentation, and additional documents verified by a notified body. Our products meet the highest quality standards, which raise the bar for medical device manufacturing, safety, and efficacy.
