In line with the new company goals, the ultraMEDIC QM team has decided to convert the existing QM system, which is based on ISO 9001, to the ISO 13485 standard in order to better monitor the procedures in accordance with the legal requirements and processes and thus offer our customers, as well as patients and users, even more safety and reliability.
ISO 13485 is based on the structure of ISO 9001, but additionally contains sector-specific requirements for the area of "medical devices". This standard, which is groundbreaking in the healthcare sector, deals with the requirements that manufacturers and providers of medical devices must fulfil in the development, implementation and maintenance of QM systems and takes into account the high demands placed on products, devices and systems that are used in the treatment of patients. The applicable "Medical Device Regulation (EU) 2017/745" (MDR) is harmonised with the ISO 13485:2016 standard.
In the past months, the ultraMEDIC quality management system was converted to the requirements of ISO 13485 and the adjustments were successfully implemented. After the positive audit by TÜV HESSEN, we now have the certification according to DIN ISO EN 13485:2016.
The award is both a reward and an incentive for us to continue to meet the requirements for quality and patient safety at the highest level.