Launch Your Medical Device
We help you launch and take your product to the markets.
Launching your new product requires a comprehensive strategic plan. Did you know that many medical devices are exempt from submissions in the USA but still may require comprehensive compliance to quality standards and FDA registration?
Whether you are starting with the US Medical Device market or you are aiming for the world, you will need a Regulatory Assessment. We integrate quickly with your team to help compare your product ideas to the regulatory requirements for market entry. These are often the backbone of your product requirements. Paladin Medical’s® expertise has resulted in countless successful product submissions. And we can start-up your quality compliance training for employees and contributors. We welcome the opportunity to help make your medical products successful.
Here is how you can start your REGULATORY ASSESSMENT:
- 1. Call or connect with us and we will get right back to you.
- 2. Of course we can execute a confidential disclosure agreement (CDA)
- 3. We can discuss your project and give you some basic questions to help us understand your product status.
- 4. If appropriate, we can do an initial regulatory assessment to help you with basic regulatory planning.
We can start with this basic product description and a comparison of your product with alternative devices or technologies. We can usually write a brief regulatory assessment at no charge. This helps us to ensure we understand the nature of your device, how FDA may regulate it, and what we anticipate for a regulatory submission. (We also offer regulatory assessment for submissions to countries other than the USA for a small fee.)
Once we have completed the preliminary assessment, we can begin to develop a work estimate for your project. We will send you our template consulting agreement and initial retainer invoice so we can get started quickly. Our goal is to develop a strategic plan so you can best integrate your development and marketing plans with regulatory applications, when needed. For more information, please see Submissions
REGISTRATION and LISTING
When you are ready for first sale in the USA, your firm will need to REGISTER and LISTi. According to regulation “An owner or operator of an establishment who has not previously entered into an operation described in § 807.20(a) shall register within 30 days after entering into such an operation and submit device listing information at that time.”
Although this should be a simple process, for whatever reason, most new companies need help navigating the FDA’s complicated system. We recommend you start this process BEFORE placing the product or action PRIOR to the deadline just to ensure all the required information can be organized. The REGISTRATION is renewed each year and with the renewal is due a fee. Each company must REGISTER, but there can be various registration categories. The fee is associated with the “registration”. Then companies “LIST” the device(s) associated with the registration category. Paladin Medical can help.
iPART 807: ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
For more details about our many services and customized training, please contact us. Please connect with us on LinkedIn
