Stage 1 audit for the ISO 13485 certification of our quality system

This week, our team spent an entire day, hardly breaking for lunch, with our notified body for the Stage 1 audit for the ISO 13485 certification of our quality system. This audit follows the preliminary audit that took place at the beginning of the year. At the end of the day, we got a ZERO “non compliance” which is a significant accomplishment.

« I have the enormous pleasure and the immense pride to announce that this audit was concluded very favorably with no “non-conformity”. If I simplify, it means that on everything that has been audited, no deviation from what is expected has been found by the auditor. » Frederic Pette, BioMAdvanced Diagnostics CEO.

This reflects the work of the entire operational team led by Nicolas Bouler, and also the mastery with which Madeleine Rambeau, our RAQA Manager, conducted the audit all day.

« This is a major step towards our certification but let’s not get ahead of ourself. The certification will be granted (or not) at the end of the next audit. This one will last 3 days and will consequently be even more thorough and demanding ». Madeleine Rambeau, BioMAdvanced Diagnostics RAQA Manager

Rest assure that Madeleine and her team remain extremely focus, continue to put in place the necessary documents and implement the required actions.