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I will provide medical device regulatory affairs and technical documentation
Sanket Bhadange
À propos de ce service
I specialize in regulatory compliance and technical documentation, with expertise in CE Technical Documentation and SFDA Technical Files, including Design & Development, Risk Management, Clinical Evaluation, Biological Evaluation Report (BER), STED, and GSPR, in compliance with EU MDR 2017/745 and MDS-REQ-1 requirements.
I also have strong experience in SOP preparation, review, and implementation in compliance with ISO 13485, EN ISO 13485, MDSAP, IMDR 2017, 21 CFR Part 820 (QMSR), and ISO 9001:2015.
My experience includes CDSCO medical device regulatory activities and licensing, BIS (ISI Marking) certification under both Foreign Manufacturers Certification Scheme (FMCS) and Indian Manufacturer schemes, and Type III Drug Master File (DMF) preparation and submission in accordance with US FDA requirements.
Additionally, I have experience with Drug-Device Combination Products (DDCP) and regulatory considerations under EU MDR Article 117.
Découvrez Sanket Bhadange
Sanket Bhadange
Medical Device Regulatory Affairs Specialist
- DeInde
- Membre depuisaoût 2026
- Temps de réponse moy.1 heure
Langues
Marathi, Anglais, Hindi
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.
