고객 후기

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.

고객 후기

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.

고객 후기

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.

고객 후기

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.

고객 후기

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.

고객 후기

우리는 심사 과정에 매우 만족했습니다. TPRG 심사는 매우 효율적으로 짧은 시간 내에 철저한 검토를 수행 할 수있었습니다. 우리는 또한 심사관분들의 세심함에 매우 감명을 받았습니다. 우리 제품에 대한 이번 심사관분은 특히 전문적인 분이셨습니다. 초기 심사 과정에서 TPRG의 답변에 대해 아주 깊은 인상을 받았습니다. 특히 소프트웨어 부분에서 묻는 질문에 대해 세부적인 영역에서부터 전체 심사 과정 특히 멸균 부분 또한 FDA 승인을 위한 조언 등 모든 심사관 분들의 구체적인 조언과 전문적 지식에 대하여 극찬합니다. 

고객 후기

TPRG에 대한 이번 경험은 이전의 타사를 통한 심사에 대한 기대를 뛰어넘었습니다. TPRG는 약속한 대로의 신속 심사 일정을 지켰습니다. 이를 통해 심사 기간에 있어 변동 없이 저희 비즈니스에 대한 일정을 차질 없이 이행할 수 있었습니다. TPRG의 모든 관계자분들은 매우 전문적이며, 항시 원활한 소통을 해주셨습니다. 심사가 완료된 후에도 지속적인 개선과 피드백에 대하여 감사드립니다. 저는 앞으로도 510(k) 심사는 TPRG를 찾을 것입니다.

고객 후기

제3자 심사기관이 제공하는 우수한 서비스에 감동받았습니다. 우리는 방사선 건강 센터, 마취, 종합 병원, 호흡기, 감염 통제 및 치과 기기의 510k 제출을 위해 제3자 심사기관을 이용했습니다. 제3자 기관은 정부 가동 중단 시 필요한 전문적인 지식, 프로젝트 관리 및 일정 준수를 명확하게 입증하는 심사 및 승인을 용이하게 할 수 있었습니다. 제3자 심사기관과의 파트너쉽으로 제품을 적시에 시장에 출시하는 목표를 달성할 수 있었습니다.

고객 후기

TPRG와 함께 일하는 것이 정말 즐거웠다! 과거에 다른 제3자 심사를 경험한 후 걱정이 많았었는데, 이번 TPRG와는 심사 과정과 빠른 시간에 대하여 매우 만족했다. 우리는 앞으로도 심사 가능한 기기는 TPRG에게 제출할 것이다.