Consulting and training for FDA, CGMP, CE Marking, 510k, PMA, hazard analysis, FDA 483, consulting and training services for all industries including Medical Device, Pharmaceutical, Diagnostic, Bio-Tech, and Software worldwide.

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