For us, the certification of our quality management system according to ISO 13485:2016 was only the first step. After receiving the certificate, the work for us did not stop at all, but rather it has only just begun.
That is why we had our internal audit carried out by experienced auditors. In a very pleasant working atmosphere, our processes, documentation and working methods were put through their paces. Because as a developer of software as a medical device up to Class III, our overall principle applies here in particular: "Only our best will do!"
During the audit, all our processes were critically reviewed. This also included our design & development processes, according to which we develop software for active implants. This was looked at very closely and (of course) there is still clear potential for improvement. In the end, we as a company and all those involved drew praise. With our guiding principles and the implementation of the requirements of the ISO 13485:2016 standard, we are well prepared for the present and the future. The external view has strengthened our belief that we are on the right path to effectively strengthen, improve and live our QMS. The expertise of the two auditors also helped us to look ahead, so that we can prevent pitfalls in the future.
One thing is clear: we are one of very few companies with this certification and the special know-how after several years of development work on medical software for active implants. tuomi is only just establishing itself as a highly skilled partner in this area. Already, more and more business opportunities are emerging, and this will pick up even more momentum in the coming years. As with NFC and intelligent link management, we are one of the first in a market that promises massive growth.