CONSULTING & SUPPORT
The services we provide include:
Medical Device (21 CFR 820, ISO13485:2016 and row)
Quality Systems Development and Implementation
Auditing
Design Control
CAPAs
Label Compliance and Control
Complaint Management
Medical Device Reporting
Recalls
Regulatory Strategies (including Device Classification) and Submissions (510(k), 513(g), De Novo)
regulatory/third-party audit responses and remediation
Development of Successful Responses to Regulatory Inspection Findings (FDA 483s, Warning Letters) and Third-Party Audit Findings
fda preparedness and gmp training
Training to Ensure Employee Readiness for FDA Inspections and Third-Party Audits
Annual GMP Training Required by FDA
Other Training as Needed
support services
Complaint Investigations and Adverse Event Reporting
Product Management
Quality System Maintenance and Updates
UDI Maintenance
China Quality, Sourcing, New Product Development, Order Management
Other Staff Augmentation Services Needed
OTC Drugs (21 cfr 211)
Quality Systems Development and Implementation
Auditing
Label Compliance and Control
Complaint Management and Reporting
supplier management
Supplier Quality Agreements
Supplier Quality Monitoring
Site Audits
Assist Suppliers with Regulatory and Quality System Compliance
Onsite China Quality Assurance/Quality Control
China Pre-shipment Inspections
China Product/Supplier Sourcing and New Product Development Oversite/Product Qualification
China Import Assistance and Shipment Tracking
China RFQ Assistance
registrations and listings
Initial and Annual Renewals (FDA, Health Canada)
Medical Device Registrations and Licensing (Canada, EU, ROW)
US Agent Services for Foreign Entities
other regulatory
Certificate for Foreign Governments
Board of Pharmacy Distributor Licensing
VA Letters of Supply
NAFTA Certificates of Origin
Upholstery and Flammability Licensing and Labeling
Assistance with FDA Port Holds
California Prop 65
dietary supplement (21 cfr 111) and cosmetics (good manufacturing practices)
Quality Systems Development and Implementation
Auditing
Label Compliance and Control
Complaint Management and Reporting
auditing
Internal Auditing to Meet Regulatory Requirements, Prepare for Third-Party Audits/Inspections and for Continuous Improvement
Support During Regulatory Inspections and Third-Party Audits
China Onsite GMP Auditing (21 CFR 820, ISO13485, ISO9001 and Social Accountability)
udi/gudid
Assistance with Creation, Registration and Listing of UDIs for Medical Devices
Product Quality
Contract Manufacturer Quality Control
Inspection Plans
Product Testing
Internal and Supplier CAPAs for Quality Assurance and Continuous Improvement
Onsite China Quality Assurance/Quality Control
fees and rates for services
Our rates and fees are designed with budget-conscious companies in mind. Depending on the project, and client preferences, we offer an affordable hourly rate of 95USD or a flat-rate fee.* Project estimates and proposals are available upon request, at no charge. Our consultants keep detailed logs of the activities performed and the time spent on your project. Project work logs will be provided to all clients upon the completion of the project, or at the completion of project milestones, as preferred. Example flat-rate fees are noted below. For additional service rates and fees, please contact us.
A representative selection of our fees (in USD) includes:
US Agent for Foreign Entities (includes FDA US Agent and FDA Official Correspondent services): $500/year
Preparation and Submission of 510(k): $8500 - combination devices, devices containing software and electric/electronic devices, $7500 - Other
Preparation and Submission of 513(g): $2500 - combination devices, devices containing software and electric/electronic devices, $1500 - Other
FDA Registration and Device Listing: $250 (includes up to 5 listings; $45 each additional listing)
Electronic Medical Device Reporting (eMDR) to FDA: $40 each
FDA Certificate for Foreign Government: $250
UDI Set-Up and Listing: $250 (up to 5 listings; $45 each additional listing)
Medical Device Quality System Documentation:
$1900 - generic templates
$2900 - customized, without Design Control (includes 2 hours of training)
$3500 - customized, with Design Control (includes 3 hours of training)
*For rates/fees for projects and services provided by our China Quality Partner, QNT Solutions, please contact Patrick Jin.