MEDICAL DEVICE DEVELOPMENT AND REGULATORY COMPLIANCE EXPERT
Reino Unido
Inglés, Francés
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Sobre mí
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.... Lee más