PRICING

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 2020 Financial year Mandatory Fees

 

FDA Annual Establishment Registration fee: $5,236

FDA 510k Medical Device User Fee Amendments (MDUFA) fee: $11,594 (Standard)

FDA 510k Medical Device User Fee Amendments (MDUFA) fee: $2,899 (Small Business)

 

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

FULL-Service Fees includes:

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)

FULL-Service Fees includes:

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 Mandatory Procedures
  • Special Templates
  • 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