Regulatory Affairs
Implementation of an Independent QMS, CE Certification and Post Market Surveillance – Galderma SA

My first key objective at Galderma SA back in 2009 was to implement a Quality Management System (QMS) and gain certification to the ISO13485:2003 standard.  In parallel we also needed to obtain the CE certification for Class III Medical Devices (injectable solutions for wrinkle filling) via the Own Brand Labelling procedures.  Galderma SA was predominantly a dermatology company, venturing into the corrective and aesthetic field and my task was to ensure all the relevant systems and processes were in place and sufficiently certified to market Class III Medical Device fillers.

CE Marking

During my time at my former company, we came across the challenge of demonstrating compliance to the 21 CFR Part 4 requirements.  The background to this was that some products in the US are considered ‘combination products’ even if registered as drug products.  We found that two of the products fell into this category one being a drug delivery type product and the other being a Transdermal patch.

Demonstrating compliance to the 21 CFR Part 4