tuomi receives ISO 13485 certification


tuomi receives ISO 13485 certification

The ISO 13485 certification is the result of an intensive phase in which we critically examined all processes and procedures of our company. These were put through their paces by TÜV Süd during a quality management audit lasting several days.

Especially in the medical sector, our customers set high standards for our applications, which we are happy to meet with our safety standards.

Therefore, we are pleased about the certification, which is a proof for our highest demands on customer satisfaction, quality and reliability. True to our QM motto 'Only our best will do', we look forward to continuing to improve our quality standards.

What is ISO 13485?

DIN EN ISO 13485 is a globally recognized standard that defines the requirements for effective quality management for manufacturers and suppliers of medical devices. ISO 13485 is a basic requirement for making medical devices available on the market in the EU. Compliance with the standard ensures the necessary quality and performance for the entire service life of the product.

Why is a QMS according to ISO 13485 important?

tuomi has been developing medical software products that comply to the European Medical Device Regulation (EU MDR) since 2016. We offer software services for cloud and mobile applications as well as engineering for medical hardware.

With our Quality Management System (QMS) we develop a wide range of software and hardware. Our QMS is based on ISO 13485:2016 and takes into account IEC 60601, IEC 82304 and IEC 62304. Therefore, we cover the entire market including medical device hardware, software as medical device, software in medical device and health software.

Find out more about tuomis Internet of Medical Things (IoMT) Services here: http://tuomi-medical.com/