Lucida Medical certified with the ISO 13485:2016 standard
We are proud to announce that Lucida Medical has been certified with the ISO 13485:2016 standard for medical device manufacturing.
Lucida Medical’s Head of Quality and Regulatory, Giovanni Maggi, spearheaded this application. We caught up with Giovanni to discuss…
“Achieving the ISO 13485:2016 certification is an incredible milestone for Lucida Medical. My previous experience in a Class IIb medical device software company was very beneficial. Previously, I had been undertaking many of these audits with the same notified body (BSI), which helped me to prepare Lucida Medical for a successful and outstanding achievement. Time constraints made Lucida’s audit a challenge, but the team pulled together to make it happen. As I have completed this process before, I quickly identified gaps, on first glance. Luckily there weren’t too many, the QMS systems was in great shape already. Usually with start-ups you expect to find major gaps, so I was delighted to find that the task ahead of me wasn’t massive.
This is largely attributed to Antony, who thoroughly understands how important the quality management system is. This is in part why I accepted the role, as I recognised this from the outset – he gets it, not all CEO’s do. That was a real selling point for me when I joined a few months ago.
Our next steps will be to achieve Class IIb under EU Medical Device Regulation which we were planning to do by the end of the year. We will also begin working on submitting our first FDA 510(k) in the USA. There are exciting times ahead!”