Clinomic is ISO 13485:2016 certified!

After receiving the ISO/IEC 27001:2013 certificate in May 2021, Clinomic took another big step into the market of medical devices: In November 2021, Clinomic acquired the ISO 13485:2016 certificate!

This standard specifies the requirements for a quality management system regarding the design and manufacture of medical devices. To receive the certificate for our company, we needed to demonstrate our ability to provide a medical device and related services that consistently meet the customer and applicable regulatory requirements. We want to give special thanks to our team in Quality and Regulatory Affairs, Martin Grüterich, Bassam Kamal, and Charlotte May, as well as our Head of Product, Jonathan Wirtz. And there is another reason to celebrate: this month Clinomic turned three years old!

Thanks to this further certification, as well as the other successes in 2021, Clinomic is gradually moving away from the status of a start-up towards an established, medium-sized company. We look forward to our journey with Mona in 2022!