
What is FDA Third Party Review?
How We Can Save You 100 Days When Time to Market Matters! Consider the potential revenue that could be generated...
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Why TPRG
Team Capabilities Teamwork Divides The Task And Multiplies The Success. We are the piece of the puzzle you are missing....
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Review Process
TPRG Review Track Our simple review process gets your device on track for formal review and clearance: Administrative Review Phase...
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THE LEADING FDA ACCREDITED REVIEW BODY
Third Party Review Group is accredited to review Medical Device Submissions on behalf of the FDA as part of the Third Party Review Program. The program allows clients to fast track their 510k submissions reducing time to market by 100 days on average.
TPRG OUSTANDING SERVICES
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- TPRG is formally recognized and accredited by FDA to perform Premarket Notification [“510(k)”] third-party reviews for all eligible devices identified in the program.
- Our accredited review capabilities encompass 7 FDA Office of Device Evaluation Divisions that reach across 13 Device Branches.
- Applicants submit their 510(k) directly to TPRG in lieu of FDA saving them precious review time and expediting their device clearance into US commerce.
- We manage the entire review process for each applicant from the time of formal submission through the final substantial equivalence determination rendered by FDA.
- Performing third party reviews is our sole business focus as we accurately and rapidly serve the needs of our customers.
TPRG ADVANTAGES
SAVE TIME!
GET TO MARKET FAST
22 to 35 Days Average Time To Clearance!
Save An Average Of 100 Days With This Expedited Process.
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SAVE MONEY!
FDA COST WAIVED
Average Price Is Less Than The FDA Traditional Program!
Speak with Our Sales Team Today.
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SAVE STRESS!
FDA EXPERTISE
Our Reviewers Have Over 20 Years Reviewing Experience!
Learn About All Our Latest Tips.
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TPRG ESSENTIALS
FDA SUBMISSION 101
HAVE QUESTIONS?
Still Confused About The Process?
Watch A Movie That Explains It All!
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NEW! RAPID 510(k)
EVEN FASTER SUBMISSIONS
Enhanced ‘Speed To Market’ Option.
Greater, Faster Feedback And Results!
ASK US HOW
TPRG CUSTOMERS
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- Our customers include some of the top 10 Global Device Manufacturers along with medium size companies thru small start-ups.
- TPRG’s current customer portfolio includes new and repeat clients located throughout the US, Canada and over 10 additional international locations.