We are delighted to inform you that on November 27, 2024, we successfully obtained the EU Quality Management System Certificate in compliance with Regulation 2017/745 Annex IX Chapters I and III (MDR) for Class IIa and IIb products, which include our medical device cleaning and disinfection solutions.
This achievement marks the culmination of a lengthy process, and we take immense pride in being among the first manufacturers of disinfection products in Europe to implement a quality management system for medical devices and secure certification under the stringent requirements of the MDR Regulation!
What does this mean for us?
We have successfully undergone a series of complex and demanding audits, covering the ISO 13485 system, technical documentation, and additional documents reviewed by the notified body.
Our products meet the highest quality standards, which enhance the requirements for the manufacture, safety, and efficacy of medical devices.
What does this mean for our Partners?
• You can purchase products compliant with the latest guidelines and quality and safety requirements.
• The product is continuously monitored on the market – it is our duty to report to the notified body all market feedback on our medical devices, ensuring a significantly higher level of oversight compared to the previous directive.
• The product is of higher quality, as the Regulation imposes far more stringent requirements than previous regulations.
