Thomas Regulatory

  Both the Medical Devices Directive 93/42/EEC (MDD) and the Medical Devices Regulation (EU) 2017/745 (MDR) require medical device makers to create a clinical evaluation for their products. A clinical evaluation's ultimate goal is to review and analyze clinical data about a medical device to offer proof of the product's clinical safety and performance. The review is based on pre and post-market clinical data relevant to the intended use of a device. Manufacturers may provide data relevant to the equipment being evaluated as well as data from comparable devices (where equivalence may be established). A Clinical Evaluation Report (CER) is a complete summary of facts relevant to the clinical use of a medical device that has been evaluated. All clinical data sources are reviewed, as well as certain non-clinical testing data that may affect the device's benefit-risk analysis. When all of the information is considered together, it provides a comprehensive knowledge of the safet...

  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-marke...