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E & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and Consulting
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info@eemedicals.com
Atlanta, GA 30339
E & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and Consulting

Consulting Packages

E & E Medicals and 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 and Consulting makes the process very straight forward with less closing costs and fewer headaches.

International Food Facility Registration & US Agent Services

Medical device establishment registration
​Annual US agent communication service
​Free electronic certificate
Free modification

For more details, Request for Quote (RFQ) now!

Medical Device Establishment Registration & US Agent Services

Medical device establishment registration
​Annual US agent communication service
​Free electronic certificate
Free modification

For more details, Request for Quote (RFQ) now!

US Domestic Food Facility Registration & US Agent Services

US domestic food facility registration
​Annual US agent communication service
​Free electronic certificate
Free modification

For more details, Request for Quote (RFQ) now!

Food, Beverage, and Supplement Label Reviews

Review FDA Label Requirements
Reduce errors that lead to FDA detention

For more details, Request for Quote (RFQ) now!

Food Canning Establishment (FCE) and Process Filings

FCE registration
Scheduled process filings (SIDs)
​Free electronic certificate
Free modification

For more details, Request for Quote (RFQ) now!

Medical Device Listings

Device listing service per product

For more details, Request for Quote (RFQ) now!

510(k) Applications for Active Devices / Non-active Devices / Implant Devices / Software Devices

Full – Service fee includes:

FDA 510k Process Guidance and Reviews
FDA 510k Documentation Reviews
FDA US Agent
FDA 510k Pre-submission
FDA 510k Final submission

Half – Service fee includes:

FDA 510k Documentation Reviews
FDA US Agent
FDA 510k Pre-submission
FDA 510k Final submission

For the FDA 510(k) Full / Half service, Request for Quote (RFQ) now!

Health Canada Medical Device Establishment License (MDEL) & Health Canada Medical Device License (MDL)

Full – Service fee includes:

MDL or MDEL Process Guidance and Reviews
MDL or MDEL Documentation Reviews
MDL or MDEL Final Submission

For the MDL or MDEL Full service, Request for Quote (RFQ) now!

CE Marking Applications for Class I Devices / Class II-A & II-B Devices / Class IS/M/R Devices / Class III Devices

Full – Service fee includes:

CE Marking Preparation & Reviews
CE Marking Authorized EU representative
CE Marking Registration

Half – Service fee includes:

CE Marking Documentation Reviews
CE Marking Authorized EU representative
CE Marking Registration

For the CE Marking of Full / Half service, Request for Quote (RFQ) now!

Registration of Devices in Other Countries

Australia / Brazil / Colombia/ Costa Rica / Egypt / Hong Kong / India / Israel / Japan / Malaysia / Mexico / New Zealand / Peru / Russia / Saudi Arabia / Singapore / South Africa / South Korea / Taiwan

For registration of devices in any of the above mentioned countries, Request for Quote (RFQ) now!

ISO 13485, ISO 9001 and ISO 14971 Certifications

E & E Medicals and Consulting 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

For the ISO and MDR certifications, Request for Quote (RFQ) now!

EU MDR Technical Documentation / Gap Analysis/ Submissions

Our expert’s review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, and other required areas. Gap analysis is carried out to ease the transition in the required areas. To meet with the New EU Medical Device Regulation (MDR) in which safety, efficacy, and performance measures are required in technical documentation, many manufacturers with CE Certification under MDD need to convert their documentation to meet the new Medical Device Regulation (MDR). The existing files shall be reviewed and upgraded with quality materials to meet all requirements. The Clinical Documentation process begins with a clearly designed Evaluation Plan which, entails the methodological and systematic approach to reach adequate reporting. It provides a step-by-step approach to conducting and documenting each procedure. In the MDR, Chapter VI, Article 61 the critical issues to be considered for clinical data with regards to general safety and performance are discussed. Our experts have developed forms and templates that can be customized for mandatory procedures of the Clinical Evaluation Record.

For the ISO and MDR certifications, Request for Quote (RFQ) now!