Testimonials

Our company was really floundering in its first attempt at a 510(k) application when someone suggested we work with TPRG. The change in focus was dramatic and their discipline put us firmly on track so that the application, once lodged, seemed to be approved within record speed.

Testimonials

I am not one to give praise to companies for doing the job they were hired to do.

However, in this case I must give the highest praise to TPRG for their professionalism, timely responses, and knowledge. The team at TPRG provide us with the guidance and knowledge that helped us, not only providing a check list of what the FDA requires for a 510(k) but the understanding of the why things are needed and the format they are needed in.

TPRG made a very complex submission process understandable to the point it not only saved our company both time and money but saved the FDA a lot of phone calls from our submission team during the process.

I am not one to refer people to businesses but with the outstanding service and commitment to excellence TPRG has shown us, I and my staff highly recommend TPRG to multiple companies that we come across internationally. We would not put our reputation on the line recommending any services without 100% confidence in who we recommend.

Testimonials

We have found the Third Party Review Group to be extremely responsive and professional in all aspects of our interaction.  We have successfully used them for clearance and will continue to do so.  Our experience, in my opinion, has demonstrated the value of the third-party review process as a way to streamline FDA clearance where appropriate and I have recommended the TPRG team to other colleagues.

Testimonials

We are very grateful for the work that Third Party Review Group did on our behalf. This was our first filing as a company, and though each of in the group has been through various 510k’s in other companies this was the first time as a group we have filed.

We started in March, and finished in July.  The Reviewer you assigned was spectacular.  She found many omissions and inconsistencies in our first full release to TPRG. One significant one (largely due to the ISO standard changing since our predicate device did their submission). This was huge because it was a six-week test, but finding it early through our process was great.

When we were very close to the end in June, the company changed the name and the reviewer’s guidance on what we had to change (14 documents) paid off.

When the file was delivered to the FDA (4^th of July week), it was impressive to get our 510k approval in 30 days with only two small issues with our labeling, that was readily fixed.
I will recommend TPRG to anyone.

Testimonials

I had a great experience working with Third Party Review Group for the submission of a traditional 510k. They were very professional, responsive, and detailed in their review. We were able to complete the submission within the expected timeline. I will be happy to return to TPRG for my next eligible submission.

Testimonials

We were very satisfied with the review process. The review was conducted efficiently and TPRG was able to conduct a very comprehensive and thorough review within a very short turn time. We were also very impressed with the attention to details of the reviewers. Our assigned reviewers were very knowledgeable. During the initial review process, we were impressed by the level of detail of the initial response from TPRG. The level of detail on the questions asked especially on the Software section shows that all the reviewers are very knowledgeable on their respective areas. We were also impressed on the knowledge demonstrated by the lead reviewer on the overall review process, the sterilization section and that lead us to FDA clearance.

Testimonials

My experience with TPRG has exceeded both my expectations and previous experiences with third party reviewers. TPRG commits to review timelines, and they meet them. This helps reduce submission review time variability, which in turn helps me meet my commitments to my business. TPRG’s staff is very professional, and the communication channels are always open. I appreciate their commitment to continuous improvement and the solicitation of feedback after the review process is complete. I will continue to use TPRG for my 510(k) reviews.

Testimonials

I am thoroughly impressed by the excellent service that Third Party Review Group provides. We utilized Third Party Review Group for a 510k submission to the Center for Devices and Radiological Health, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices. Third Party Group was able to facilitate a review and approval during a government shutdown clearly demonstrating their expertise, project management, and adherence to timelines. As a result of our partnership with Third Party Review Group, we were able to meet our goal of bringing our product to the marketplace in a timely fashion.

Testimonials

It was a pleasure working with TPRG! After using other Third Party Reviewers in the past we were skeptical of using the service again but were extremely pleased with the process and quick review time. We plan to use their service for future eligible submissions.