Third Party Review Group

Third Party Review Group

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Third Party Review Group is accredited to review Medical Device Submissions on behalf of the FDA as

FDA Mandatory eStar/ESG submission and Expedited 510K Clearance | Third Party Review Group 04/25/2023

The FDA announces mandatory eStar/ESG submission for 2023. TPRG process makes submission easier. See how we can help!

FDA Mandatory eStar/ESG submission and Expedited 510K Clearance | Third Party Review Group FDA Mandatory eStar/ESG submission and Expedited 510(k) Clearance The Third Party Review Group or just TPRG for short is an FDA accredited review organization. There are very few companies qualified to review 510K submissions for the FDA and TPRG is celebrating their 13th year performing this work f...

Third Party Review Group 02/04/2023

Many are not aware of a fast path to 510k clearance of medical devices. The FDA has a program that will allow certain medical devices to use an alternative path to clearance. Average days to clearance is 25 to 37 days.

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Third Party Review Group Team Capabilities Teamwork Divides The Task And Multiplies The Success. We are the piece of the puzzle you are missing....

06/22/2020

Are thermometers eligible for expedited 510K FDA clearance? Yes, Thermometers are eligible for the special FDA 510k clearance program. Get your 510k cleared to market in 40 to 60 days with Third Party Review Group. Our team of experienced reviewers can get your thermometer cleared fast. Contact TPRG Today! https://fdathirdpartyreview.com/request-a-quote/

05/27/2020

Third Party Review Group simple review process gets your device on track for formal review and clearance:
• Administrative Review Phase
• Substantive Review Phase
• FDA Review Phase

TPRG is formally recognized and accredited by FDA to perform premarket notification third-party reviews. We value our customers and the services we provide.

Third Party Review Group has over 100 years combined experience and brings a highly interactive, nimble process to our clients. Third Party Review Group has the experience to understand the requirements and guidelines and has used this experience to create a very simple and efficient process for you. TPRG get you cleared fast allowing you to move forward with your business. Contact TRPG Today!

05/23/2020

PARTNER WITH TPRG!
Third Party Review Group has built a team of experts comprised of varied backgrounds and experience levels that will ensure your FDA 501k review work is delivered on time and, crucially, within budget!

TPRG has:
7 FDA Office of Device Evaluation Divisions
14 Device Branches
Over 1,200 Product Codes
23 Accredited Reviewers Available

TPRG IS HERE TO HELP YOU! Contact Us Today!

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7 Giralda Farms, Suite 120A
Madison, NJ
07940