-
510(k) Full Launch
Regular price Rs.3,316,489.00 PKRRegular price -
510(k) Starter Pack
Regular price Rs.819,233.00 PKRRegular price -
Class I Market Entry Pack
Regular price Rs.523,481.00 PKRRegular price -
QMSR & ISO 13485 Gap Audit
Regular price Rs.728,659.00 PKRRegular price -
GUDID & UDI Setup
Regular price From Rs.55,454.00 PKRRegular price -
Medical Device Label, IFU & UDI Review
Regular price Rs.227,729.00 PKRRegular price -
FDA Additional Information (AI) Response
Regular price Rs.728,659.00 PKRRegular price -
Special 510(k) for Device Modifications
Regular price Rs.1,652,884.00 PKRRegular price -
Traditional 510(k) Submission (eSTAR to K Number)
Regular price Rs.2,577,109.00 PKRRegular price -
FDA Pre-Submission (Q-Sub) Package
Regular price Rs.913,504.00 PKRRegular price -
510(k) Gap Analysis & eSTAR Readiness Review
Regular price Rs.486,512.00 PKRRegular price -
510(k) Predicate Device Search & SE Table
Regular price Rs.264,698.00 PKRRegular price -
FDA Small Business Determination (SBD)
Regular price Rs.153,791.00 PKRRegular price -
US Agent for Medical Devices (12 months)
Regular price Rs.173,754.00 PKRRegular price -
FDA Device Registration Renewal (1 Oct – 31 Dec)
Regular price Rs.99,816.00 PKRRegular price -
FDA Medical Device Establishment Registration & Listing
Regular price From Rs.27,727.00 PKRRegular price -
FDA Device Classification & 510(k) Pathway Report
Regular price Rs.116,822.00 PKRRegular price
