llms.txt — MedReg AI Context

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Summary

MedReg provides regulatory consulting for CDSCO India, FDA 510(k), and CE Marking. We specialize in Class A, B, C, and D medical devices.

Entity: MedReg Consultancy LLP
Tagline: Let's Decode The Regulations
Headquarters: 11^th Floor Block C – 1105, 1106 Titanium Business Park, Behind Divya Bhaskar Press, Near Makarba Railway Crossing, Makarba, Ahmedabad, Gujarat, 380051, India.
Phone: +91 88664 61989, +91 63523 88194
Email: enquiry@medreg.in

• India: Manufacturing License, Import License, Clinical Trials, Free Sale Certificate, Authorized Agent, Wholesale License and more.
• Europe: CE Mark, Technical Master File, Gap Analysis, Clinical Evaluation, PMS Report, Risk Analysis (EN ISO 14971), PRRC, Authorized Agent through channel partners.
• USA: FDA classification, establishment registration and device listing, 510(k), Small Business Determination, Q-Submission, GUDID, U.S. Agent, labelling, QMSR, training, regulatory reporting, design controls, biocompatibility, DMR, DHR, import and export, Indian Authorized Agent, Indian supplier evaluation.
• Other markets: Technical File / Dossier per IMDRF and GHTF, QMS Documentation, Internal Audit, Supplier Development, Process Validation.