MedDev Experts is a leading Regulatory Consultant in India, specializing in Medical Device and In-Vitro Medical Device Licenses. We provide complete guidance for compliance with the Medical Device Rule, 2017, from registration with CDSCO to license acquisition. Our expertise spans Pharmaceutical, Cosmetics, Wholesale, AYUSH, Food (FSSAI), and Medical Device Manufacturing Units. We assist in establishing Quality Management Systems, offering training and certifications like ISO 9001, ISO 13485, ISO 14001, HACCP, HALAL, SA 8000 & UK CA, and CE Marking. Our services include device classification, Technical File preparation, and obtaining the CE Certificate per REGULATION (EU) 2017/745. For clients in the US market, we help with FDA Facility Registration, product registration, NDC Number acquisition, and 510K Submission. We also support compliance with Unique Device Identification (UDI) requirements for US FDA, EUDAMED, and CDSCO, and data submission to GUDID.

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