Count on our experience to help you take your product to the market.
Launching your new product requires a comprehensive strategic plan that involves understanding not only the regulatory pathways available to you, but how FDA may perceive your product in light of features, benefits and risks. We integrate quickly with your team to help with the project planning and execution.
Paladin Medical’s® expertise and commitment to high standards have resulted in countless successful product submissions and robust compliance training for our clients. We welcome the opportunity to help make your medical product a success.
1. Send us your confidential disclosure agreement (CDA) or we can provide you with a template.
2. We begin with a regulatory assessment for your project.
Give us a basic device description and a comparison of your product with alternative devices or technologies. Tell us the differences your product will offer. (Your existing presentation materials are often sufficient.)
3. We can write a brief regulatory assessment at no charge to ensure we understand the nature of your device, how FDA would regulate it, and what we anticipate for the 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 right away. Our goal is to develop a submission plan for you as quickly as possible to integrate with your development and marketing plans. Refer to Submissions