We help medical device manufacturers and distributors launch their devices in the US market by conducting efficient reviews with competitive pricing.
Global Quality Regulatory Services (GQRS) is proud to be a trusted partner and FDA-accredited 510(k) Third Party Review Organization of medical devices.
Experience
FDA-accredited reviewer of 510(k) submissions for an extensive list of medical devices eligible for a third-party review. We are a large team of highly experienced reviewers dedicated to seamlessly reviewing your submission.
Efficiency
We understand the benefit of getting your device quickly to market and can save you up to 70% of the FDA review time (average of 50-60 with GQRS vs 177 days).
Flexibility
We will accommodate your deadlines, streamline the workflow accordingly, make our review process as interactive as possible, and offer you unlimited real-time communications with us.
Competitive Cost
One competitive fee to conduct the review and communicate with the FDA on your behalf - No additional FDA User Fee or any hidden costs.
Exceptional Quality Service
Dedicated to delivering excellent customer service and creating open and honest relationships with our clients. We encourage and appreciate client feedback and are committed to addressing any concerns to your satisfaction.