In 2009, I worked on an exciting project to transfer the manufacturing facility and product lines from Europe to Canada. During the transfer plan, I visited the facility in France as well as I performed the audits of critical laboratory suppliers in France. The plan was moving forward until the entire QMS for injectable product lines (class III) was implemented in new location. A conformity assessment was then conducted by notified body under MDD in Canada. Stressful time for all of us, but it was paid off by getting all products CE marked and the company obtained certification ISO 13485:2003 in 2010. Hurray
