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Sanket Bhadange
@sanket4597
Medical Device Regulatory Affairs Specialist
Inde
Anglais, Hindi, Marathi
À propos de moi
Welcome! I’m Sanket Bhadange, a Regulatory Affairs professional with extensive experience in Medical Device Regulatory Affairs. I specialize in CE Technical Documentation and SFDA Technical Files, including Design & Development, Risk Management, Clinical Evaluation, BER, STED, and GSPR, in compliance with EU MDR 2017/745 and MDS-REQ-1. Experienced in SOPs, ISO 13485, EN ISO 13485, MDSAP, IMDR 2017, 21 CFR Part 820 (QMSR), CDSCO, BIS certification, and Type III DMF submissions. I also support DDCP regulatory requirements under EU MDR Article 117.
Compétences
Sanket Bhadange
hors ligne •
Temps de réponse moyen de 1 heure
Voir mes services
Réglementation des dispositifs médicaux
I will provide medical device regulatory affairs and technical documentation
