TPRG is the missing piece of the puzzle that can help you take your medical device to market. We understand the significance of a fair, concise, and swift review of your 510(k) submission, and that’s why we’ve assembled a team of some of the industry’s most talented and experienced regulatory experts.
At TPRG, we’re committed to providing personalized support to meet the unique needs of each of our clients. With our FDA accreditation to review 510Ks on their behalf, our clients can expect much faster clearance timeframes compared to those who file directly with the FDA.
Our expertise and experience enable us to quickly move through the review process helping you achieve your objectives and launch your medical device in the US market as efficiently and fast as possible.
So why not work with TPRG today and let us review your 510K? With us by your side, you can rest assured that your 510(k) submission is in the hands of the best and most qualified in the business.
Team Capabilities
Teamwork Divides The Task And Multiplies The Success.
We have built a team of experts comprised of varied backgrounds and experience levels that will ensure your review work is delivered on time and, crucially, within budget.
With our main office located in Warren, NJ, our recently opened satellite offices in San Diego, CA, and the San Francisco Bay Area and our new branch office in South Korea, our reviewers are strategically placed in multiple time zones to satisfy every client need regardless of location.
Because we specialize only in performing Third Party Reviews, we feel TPRG is the Professional’s Choice for FDA Third Party Review.
Our dedicated Third Party Review team of professionals is comprised of some of the top leaders in the medical device arena with accreditation capabilities covering 7 FDA Office of Health Technology Divisions that reach across 14 Device Branches and over 1,200 product codes.
FDA Third Party Review Device Branches include:
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- Anesthesiology
- Cardiovascular
- Dental
- Ear Nose & Throat
- Gastroenterology
- General & Plastic Surgery
- General Hospital
- Immunology
- Neurology
- Obstetrics/Gynecology
- Ophthalmic
- Orthopedic
- Physical Medicine
- Radiology
With an average of 30 years of US and International industry 510(k) submission experience, our reviewers are poised and ready to meet your company needs.
TEAM COMMITMENT
The success of any business depends on the way it treats its customers. As industry experts, we take great pride in ourselves, our customers and the service we deliver. This pride is paramount to our commitment to your company and our binding responsibility as an accredited FDA Third Party Review Agency.
7 FDA Office of Health Technology Divisions
14 Device Branches
Over 1,200 Product Codes
TPRG is here to help you!