TPRG is the critical partner you need to successfully bring your medical device to market. We recognize the importance of an accurate, thorough, and expedited 510(k) review, which is why we’ve assembled a team of the industry’s most skilled regulatory experts to support your submission.
As an FDA-accredited third-party reviewer, TPRG offers personalized, expert guidance tailored to meet the unique needs of each client. By leveraging our services, you can significantly accelerate your 510(k) clearance process, saving valuable time compared to submitting directly to the FDA.
With our extensive experience in FDA regulatory compliance and a focus on substantial equivalence determinations, we streamline the entire review process, ensuring that your device is cleared for the US market quickly and efficiently.
Partner with TPRG for your 510(k) submission, and trust that your medical device review is in the hands of the best in the business, ensuring a faster and more reliable path to market.
Team Capabilities
Teamwork Divides The Task And Multiplies The Success.
At TPRG, we’ve assembled a diverse team of regulatory experts with extensive experience in FDA 510(k) submissions, ensuring your review process is completed efficiently, on time, and within budget. Our team’s varied backgrounds bring a wealth of knowledge and expertise to each submission, driving success for our clients.
With our headquarters in Madison, NJ, and strategically located satellite offices in San Diego, CA, the San Francisco Bay Area, and our new branch office in South Korea, we operate across multiple time zones. This global presence allows us to provide seamless 510(k) review services, ensuring that no matter where you are, our team is ready to meet your needs promptly and effectively.
At TPRG, we focus exclusively on Third Party Reviews, making us the Professional’s Choice for FDA 510(k) review services. Our sole dedication to this field ensures that we offer unmatched expertise and precision.
Our team is made up of some of the top leaders in the medical device industry, with extensive FDA accreditation across 7 FDA Office of Health Technology Divisions, covering 14 Device Branches and over 1,200 product codes. This allows us to provide comprehensive review capabilities for a wide array of medical devices, helping expedite the 510(k) clearance process.
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 510(k) submission experience, our reviewers are ready to address your regulatory needs, ensuring your medical device gets to market faster. Trust TPRG to deliver the expertise and efficiency required for successful third-party reviews.
TEAM COMMITMENT
At TPRG, we believe the success of any business hinges on how it treats its customers. As industry experts, we take immense pride in our work, our clients, and the exceptional service we deliver. This pride drives our unwavering commitment to your company and reinforces our responsibility as an FDA-accredited Third Party Review Agency.
Our expertise spans:
- 7 FDA Office of Health Technology Divisions
- 14 Device Branches
- Over 1,200 Product Codes
With a proven track record in 510(k) submissions, we are dedicated to providing timely, accurate, and efficient reviews to help you bring your medical device to market faster. TPRG is here to support you!