Your Best 510k Consultant Is Here At TRR

 

FDA clearancpe is vital for the success of your medical device product marketing and we at Thomas Regulatory Resolutions help you navigate the 510(k) submission process quickly and efficiently. Missing information and gaps in your 510(k) submission can cause errors and delay your product launch by months. For your 510(k) submission, our 510k Consultant offer individualized initial advice to assist you to expedite the certification process and reach the market on schedule. Our lead consultant has worked directly with FDA affiliate managers and reviewers, which means extensive product knowledge and industry experience will be passed on to you during your 510(k) submission review.

Are You Prepared Everything For Your 510(K) Submission?

Simply put, a 510(k) is a pre-market submission to the FDA indicating that a marketed device is at least as safe and effective (essentially equivalent) as a device already legally marketed (21 CFR 807.92(a)(3)) that does not apply PMAs (pre-market authorization – most Class III devices).[2] With all of the above in mind, Do you believe your business is prepared to provide the FDA with a 510(k) for your Class II medical device?

TRR Is There For You

Thomas Regulatory Resolutions (TRR) go beyond product testing, inspection and certification and are a comprehensive quality assurance supplier to the industry worldwide. We provide our customers with cutting-edge and specialized inspection, testing, and certification services thanks to our global network of cutting-edge technology and sector-leading technical know-how. We offer a systematic approach to support our customers' quality efforts in all areas of their operations, including R&D, raw materials, component suppliers, manufacturing, transportation, distribution and retail channels, and customer management.

TRR provides comprehensive quality assurance 24/7 with our industry-winning processes and customer-centric culture. Whether your business is local or global, we can help ensure that your products meet quality, health, environmental, safety and social responsibility standards in almost any market around the world. We have extensive global accreditations, recognitions and agreements, and our knowledge and expertise in overcoming regulatory, market and supply chain barriers are second to none.

Finally

Your medical device consultant should also act as a regulatory strategist and help you determine in advance whether a 510(k) is applicable, if so, what type, and what is their potentially more efficient way to bring the medical device to market. For all your consultation needs, in particular, if you require assistance with your 510(k) filing or quality management system, get in touch with Thomas Regulatory Resolutions right away. We have product registration experts from the fields of quality implementation, quality control and regulation. As noted above, a quality management system in the manufacture of a medical device is a prerequisite for 510(k) submission and FDA inspection readiness depends on it. But that's not the only document needed to prepare a 510(k). There are several additional requirements for your 510(k) submission package. It might be time to contact the top 510k Consultant if you are not familiar with these criteria or if you have concerns regarding your quality management or CMO.

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