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oliviaga
@oliviagarc
EU MDR and CE Marking Expert
États-Unis
Anglais, Français, Allemand, Néerlandais
À propos de moi
I am a Regulatory Affairs Consultant specialized in EU MDR compliance, CE marking, ISO,QMS, FDA compliance, MHRA registration, and UKCA certification for medical devices, healthcare products, and biotech companies. I help startups and manufacturers achieve EU, UK, and US regulatory approval through technical documentation, EUDAMED registration, SRN acquisition, FDA registration, risk assessment, and ISO certification documentation. My services include technical file preparation, regulatory documentation, internal audits, and compliance ready QMS systems aligned with EU MDR 2017/745, ISO 13485.
Compétences
oliviaga
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Voir mes services
Certifications et réglementations
I will do eu mdr medical device ce marking, iso 27001, fda compliance, ukca and mhra
Immatriculation d'entreprise
I will do fda registration, 510k compliance and approval expert US, eu, canada products
