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Lidia
@lidia356
Business Specialist
Royaume-Uni
Anglais, Espagnol, Français, Allemand
À propos de moi
With over a decade of expertise, I offer specialized medical device regulatory services, ISO documentation, and compliance. As an IRCA Approved Lead Auditor for ISO 9001:2015 & ISO 13485:2016, I ensure top tier standards. Proficient in navigating MDR 2017/745, MDD, FDA, cGMP, and ISO standards, I provide tailored compliance strategies, including technical writing and global regulatory affairs. My expertise extends to HSE plans and SFDA documentation, making me a reliable partner for sustained success.
#MedicalDevices #ISO
Compétences
Lidia
hors ligne •
Voir mes services
Certifications et réglementations
I will provide iso 13485 medical device compliance, quality management system
