Célia Ludovino
Graduated in Chemical Engineering by the Lisbon Superior Institute of Engineering. Post Graduated in Medical Devices by the Pharmacy University of Lisbon and Specialist in Regulatory Affairs and Technical Direction by Invictus Sciences, Lisbon.
Lead Auditor in the ISO 13485 MD-QMS certified by IRCA. Started in 2000 at BHL-Medical working on MDD 93/42/EC to obtain the EC mark for the Medical Devices manufactured by the company.
In 2003 started with the company certification under ISO 13485. Along the years have been dedicated to the maintenance of the company QMS and the devices CE mark under MDD and to the validation of critical process, Packaging and EO sterilization.
In 2022 started to be dedicated to the MDR Regulation and the transition from MDD to MDR.