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Jessica W
@jessicaw_pro
MEDICAL DEVICE DEVELOPMENT AND REGULATORY COMPLIANCE EXPERT
Royaume-Uni
Anglais, Français
À propos de moi
I am a strategic materials engineer expert with many years of proven experience. I specialize in product development, biocompatibility testing (ISO 10993), risk management (ISO 14971), FDA 510(k) submissions, and EU MDR compliance, ensuring devices meet the highest safety and regulatory standards. My expertise extends to materials characterization, failure analysis, toxicology assessments, and innovative engineering solutions, enabling clients to bring safe, effective, and compliant products to market with confidence.
Compétences
Jessica W
hors ligne •
Temps de réponse moyen de 5 heures
Voir mes services
Stratégie commerciale et innovation
I will provide eu mdr and ce medical device strategy with iso 13485
Stratégie commerciale et innovation
I will create iso 9001, 14001, 45001 certification, audit and documentation
