• Consulting

  • Auditing

  • Registration

  • Submission

  • Compliance

  • Certification

  • Training

    

  

 

 

 

FDA Regulatory Experts
 

We provide consulting and training services for meeting requirements for all industries including Medical Device, Pharmaceutical, Diagnostic, Bio-Tech, Software, FDA, and CGMP for countries worldwide.

A leader in consulting, training, development, verification, certification, auditing, translation services, for the following:

  • Software Verification and Validation

  • FDA QSR/GMP, ISO 13485 Audit

  • DA QSR/GMP, ISO 13485 Implementation Assistance

  • Design Control Compliance

  • Risk Assessment/Hazard Analysis

  • 510(k)

  • PMA

  • IDE

  • CE Mark

  • Electronic Recordkeeping

  • IEC 60601 Compliance

  • FDA Submissions: 510(k) IDE, PMA, Product Reports

  • Software Quality Compliance

  • Medical Device License Submissions

  • FDA 483 & Warning Letter (response & resolution support)

  • CGMP Compliance

  • FDA Registration

  • Agent for Non-USA Firms

  • Medical Device Reporting (MDR)

  • Post Market Surveillance

  • CE Marking European MDD 90/385/EEC

  • CE Marking European MDD 93/42/EEC

  • CE Marking European MDD 98/79/EEC

We  provide consulting and training services in partnership with AccelCert and Quality University.

Frequently Asked Questions

 

Who is the FDA?

 

FDA stands for the Food and Drug Administration. It is a US government agency of the US Department of Health and Human Services.

 

What is the responsibility of the FDA?

 

Its responsibility includes the regulation of:

  • Food

  • Medication

  • Vaccines

  • Biopharmaceuticals

  • Blood Transfusions

  • Medical Devices

  • Tobacco

  • Dietary Supplements

  • Cosmetics

  • Veterinary Products

  • Electromagnetic Radiation Emitting Devices

 

Where can I get more information about the FDA?

 

Visit the FDA’s official site at: http://www.fda.gov/ .

 

Where can I find information about the FDA’s different regulations?

 

Please visit the FDA’s regulation database at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

 

Where can I get with filing for 510k and/or PMA for medical device products?

 

We can provide you with consulting and training support.

 

Where can I get training for FDA?

 

ISO Accelerate Group offers online, onsite, and customized training. Please visit http://www.accelcert.com for more information.

 

Where can I get online training and certification?

 

Quality University provides online training and certification. For more information, follow this link: http://www.qualityuniversity.com

 

My company is ISO 9001 certified. Where can I get help with compliance with FDA?

 

Please visit http://www.accelcert.com for more information.

 

Where can I get a free estimate for FDA consulting?

 

Please contact Accelcert at 1-888-476-9103 for specific quotes.

 

Where can I get a free estimate for FDA certification?

 

Please contact Accelcert at 1-888-476-9103 for specific quotes.

 

Where can I get a free audit checklist for FDA?

 

Please contact Accelcert at 1-888-476-9103 for specific quotes.

 

 

*The above information is provided for the better understanding of the specific standard, certification process, consulting, and training resources. We do recommend that you or your company refer to the latest standards and verify information and/or contact the resources listed, or as applicable.

 

  
 

ONLINE TRAINING OFFERED BY QUALITY UNIVERSITY

Select a course below for more information:

 
 

FDA-GMP Good Laboratory Practice for nonclinical (21 CFR part58) Implementation and Auditing.

 
 

FDA/CGMP Medical Devices Executive Overview & Management Review for meeting FDA requirements

 
 

FDA/CGMP Blood - Implementation & Audit/Auditor

 
 

FDA/CGMP Drug (Pharmaceutical) - Implementation and Audit/Auditor (21CFR210-211)

 
 

FDA/CGMP Food - Implementation & Audit/Auditor

 
 

FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation

 
 

FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation in Chinese

 
 

FDA/CGMP for Medical Devices, Auditing/ Auditor/Implementation in Spanish

 
 

FDA/CGMP Medical Devices Executive Overview & Management Review for meeting FDA requireme in Spanish

 
 

FDA/CGMP Medical Devices Executive Overview & Management Review for meeting FDA requirements Chinese

 
 

FDA/CGMP Medical Devices Introduction & Employee Overview

 
 

FDA/CGMP Medical Devices Introduction & Employee Overview in Chinese

 
 

FDA/CGMP Medical Devices Introduction & Employee Overview in Spanish

 
 

8 D Problem Solving Methodology, Corrective Action, and Good Business Practices

 
 

Aspect, Significant Impact Process/Calculation Method for meeting ISO 14001

 
 

Business Continuity/Contingency Planning Implementation and Auditing/Auditor

 
 

CE Marking (90/385) for Active Implantable Medical Devices- Essential Requirements Only

 
 

CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing

 
 

CE Marking (93/42 ECC) for medical devices- Essential Requirements only

 
 

CE Marking (93/42 ECC) for medical devices- Implementation and Auditing

 
 

Environmental, Health and Safety Training for meeting DOT, ISO 14001, OSHA, OSHA 18001,.........

 
 

ESD EMPLOYEE AWARENESS

 
 

ESD Overview, Implementation and Auditing /Auditor

 
 

FMEA, Potential Failure Mode Effect Analysis

 
 

FMEA, Risk Analysis for Medical Devices

 

References and Useful Links:

FDA History

ISO Accelerate

Quality University