Provide end-to-end regulatory consulting to medical device manufacturers, importers,
and legal manufacturers.
-Independently handle CDSCO registrations & licenses:
•Class AD medical devices
•MD-3, MD-5, MD-9, MD-14, MD-15, MD-42, MD-43
•Import, manufacturing, loan license & post-approval changes
•Prepare, review, and validate CE MDR (2017/745) documentation for clients:
Technical File / Design Dossier
•GSPR checklist
•Risk Management (ISO 14971) PMS & PMCF plans
-CER (in coordination with clinical experts) Support US FDA compliance & submissions:
•Establishment Registration & Device
•Listing 510(k) submission strategy and review
-FDA QSR (21 CFR 820) gap assessments
-Act as a regulatory interface between clients, notified bodies, CDSCO, and international
consultants.
-Team Leadership & Mentoring
-Provide ISO 13485 consulting:
•QMS setup, gap analysis, and optimization SOP drafting and review
-Act as Lead Auditor / Internal Auditor for:
•ISO 13485 internal audits
•Supplier audits
-Mock regulatory audits (CDSCO / FDA / NB readiness)
-Review CAPA, change control, deviations, and risk files from a regulatory risk perspective.