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E & E Medicals Consulting Service Fees
Most clients are always confused about the cost of FDA Fillings because their signed agreements with other consulting firms include additional fees based on the complicated process involved in answering FDA queries. E&E Medicals makes the process very straight forward with less closing costs and fewer headaches.
FDA 2021 Financial year Mandatory Fees
FDA 510k Review Fees (MDUFA): $3,108 (Small Business)
FDA 510k Review Fees (MDUFA): $12,432 (Standard)
FDA Annual Establishment Registration fee: $5,546 (Paid only after 510k clearance)
E & E Medicals Consulting Service Fees
Below is the pricing for the services we provide to our clients:
International Food Facility Registration and US Agent Services
- International food facility registration
- Annual US agent communication service
- Free electronic certificate
- Free modification
$799 Add to Cart
Medical Device Establishment Registration and US Agent Services SAMPLE FDA CERTIFICATE
- Medical device establishment registration
- Annual US agent communication service
- Free electronic certificate
- Free modification
$899 Add to Cart
US Domestic Food Facility Registration and US Agent Services
- US domestic food facility registration
- Annual US agent communication service
- Free electronic certificate
- Free modification
$859 Add to Cart
Food, Beverage, and Supplement Label Reviews
- Review FDA Label Requirements
- Reduce errors that lead to FDA detention
$959 Add to Cart
Food Canning Establishment (FCE) and Process Filings
- FCE registration
- Scheduled process filings (SIDs)
- Free electronic certificate
- Free modification
$799 Add to Cart
Medical Device Listings
- Device listing service per product
$299 Add to Cart
510(k) Applications for ACTIVE DEVICES /NON ACTIVE DEVICES / IMPLANT DEVICES/ SOFTWARE DEVICES
FDA 510k Process Guidance and Reviews
FDA 510k Documentation Reviews
FDA US Agent
FDA 510k Pre- Submission
FDA 510k Final Submission
HALF Service Fees includes:
FDA 510k Documentation Reviews
FDA US Agent
FDA 510k Pre- Submission
FDA 510k Final Submission
FULL/HALF SERVICE - FDA 510(k) Request for Quote (RFQ)
Health Canada Medical Device Establishment License (MDEL) & Health Canada Medical Device License (MDL)
MDL or MDEL Process Guidance and Reviews
MDL or MDEL Documentation Reviews
MDL or MDEL Final Submission
FULL SERVICE - Request For Quote (RFQ) - MDL/MDEL
CE Marking Applications for CLASS I DEVICES / CLASS IIA &IIB DEVICES / CLASS IS/M/R DEVICES/ CLASS III DEVICES
FULL-Service Fees includes:
CE Marking Process Guidance
CE Marking Preparation & Reviews
CE Marking Authorized EU representative
CE Marking Registration
HALF Service Fees includes:
CE Marking Documentation Reviews
CE Marking Authorized EU representative
CE Marking Registration
FULL/HALF SERVICE - Request For Quote (RFQ) - CE Marking
For Registration of Devices in the following countries:
Australia / Brazil/Costa Rica / Hong Kong / India/Japan/Malaysia/ Costa Rica/Hong Kong/India / Colombia/ South Africa/ South Korea/ Egypt / Israel/ Mexico / Saudi Arabia/ Singapore/ New Zealand / Peru/ Russia/ Saudi Arabia/ Singapore/ Taiwan
Request for Quote (RFQ) Medical Device Registration
ISO 13485, ISO 9001, and ISO 14971 Certification
E &E medicals consultants will work with your organization in understanding the vital needs of your company processes and prepare you for both Certification and FDA Audits. We shall provide you the following:
- Completely Written Quality Manual
- Completely Written QMS Mandatory Procedures
- Special Templates for Medical Device Quality System
- Auditing and Training
Request for Quote (RFQ) ISO 9001/ISO 14971 Implementation/Certification
Request for Quote (RFQ) ISO 13845/ISO 14971 Implementation/Certification
Request for Quote (RFQ) - MDR Technical Documentation