Properly classifying your device early in the development process is critical. JALEX Medical can develop a regulatory strategy and classification for your medical device, so you can plan your go-to-market strategy. When you’re ready to move forward, our experts can help you navigate regulatory process with FDA and international regulatory agencies.
During the development of your regulatory strategy, you’ll evaluate and determine the best pathway forward for your product. You’ll need to consider having a pre-submission meeting, submitting the device as a 510(k) or a de novo, breakthrough device designation, etc. An experienced medical device regulatory partner can help you appraise these considerations early, and ultimately determine the strategy that makes the most sense for your device and your business. Choosing the right partner means finding someone who can walk alongside you every step of the way, so you can decide what’s best for you and accomplish your goals.
A 510(k) is premarket submission made to FDA to demonstrate your device is safe and effective for use and substantially equivalent to a legally marketed device. Your 510(k) submission must include technical information that compares your device to one or more predicates, or similar legally marketed devices. These submissions, as well as other aspects of the submission process, must meet FDA’s necessarily thorough standards.
Navigating the 510(k) submission process can be very challenging, and you’ll need to partner with a firm that has broad experience and expert knowledge. JALEX Medical exclusively focuses on bringing medical devices to market, and we have successfully submitted dozens of 510(k) for our clients.
JALEX Medical’s regulatory consulting team will help you understand the UDI requirements for your device. Our team can help develop processes for identifying and submitting data to the FDA’s Global Unique Device Identification Database (GUDID). Furthermore, we can provide training for all essential UDI activities.
Additionally, JALEX helps in listing your device, as well as registering your establishment. We provide explicit instructions to ensure you are under the correct establishment and product listing.
Our support doesn’t stop once your product is cleared for market. JALEX remains available to assist with post-market activities. Our team will help you respond to any FDA compliance issue. Contact our team today. Give yourself peace of mind knowing JALEX’s experts are available to help you navigate the regulatory process.
Regulatory Affairs Services
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