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Consulting
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Auditing
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Registration
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Submission
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Compliance
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Certification
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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:
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Software Verification and Validation
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FDA QSR/GMP, ISO 13485 Audit
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DA QSR/GMP, ISO 13485 Implementation Assistance
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Design Control Compliance
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Risk Assessment/Hazard Analysis
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510(k)
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PMA
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IDE
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CE Mark
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Electronic Recordkeeping
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IEC 60601 Compliance
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FDA Submissions: 510(k) IDE, PMA, Product Reports
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Software Quality Compliance
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Medical Device License Submissions
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FDA 483 & Warning Letter (response & resolution support)
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CGMP Compliance
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FDA Registration
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Agent for Non-USA Firms
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Medical Device Reporting (MDR)
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Post Market Surveillance
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CE Marking European MDD 90/385/EEC
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CE Marking European MDD 93/42/EEC
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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:
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Food
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Medication
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Vaccines
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Biopharmaceuticals
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Blood Transfusions
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Medical Devices
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Tobacco
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Dietary Supplements
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Cosmetics
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Veterinary Products
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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.
References and Useful Links: