BSI ISO 13485 certification

ISO Certification Renewal Success!

We are proud and delighted to have successfully concluded another year of audit for our ISO 13485:2016 certification for Medical devices with our auditor, the British Standard Institute (BSI).

An audit like no other audits

This year’s audit was like no other before since the COVID-19 pandemic made it hard to welcome the auditors to our offices. Mimetis’ offices are in Barcelona, Spain, and we were also under strict national lockdown. However, we managed to undertake the audit process via our secure online platform, where the British Standard Institute audited Mimetis during several intensive days. Additionally, we successfully passed the mandatory onsite audit in our manufacturing facility. 

An agile Quality Management System

The auditors were extremely complimentary about the new Quality Management System (QMS) that we had recently implemented. Moreover, the agility of our QMS facilitated this remote audit. It allowed them to have easy and sufficient access to our files to conduct the audits in full. Mimetis team was very well prepared and demonstrated professional maintenance of the required ISO 13485 performance standards.

What does holding an ISO 13485 mean for Mimetis?

In other words, this audit certifies that Mimetis continues to operate in a Quality Management System which complies with the requirements of ISO 13485: 2016 and EN ISO 13485. This certification covers the scope of the design, manufacture, and distribution of sterile synthetic bone graft substitutes for orthopaedic and dental applications.

Future Plans

Mimetis is committed to continuous improvement, building on our ongoing achievements. Our next step is to make a transition from MDD to the new Medical Devices Regulation (MDR 2017/745). We are confident we will achieve this milestone.