- Our product development services start with a comprehensive regulatory assessment to determine the classification of your medical product and the FDA regulatory requirements to get your product to market. If you anticipate an international market first, we can advise on regulations in the countries of your preference.
- Our product development services will lay out your project plan or work with your planners to define your milestones and most efficient development path.
- Based on the project plan we can help you to determine the budget for product development.
By working “virtual”, you can keep your start-up costs low.
- Using our client portal, your support team can maintain real-time current documents and team minutes as easily as maintaining files on their own computer.
Medical device development can be a national and international endeavor and we know how to work literally around the globe, 24 hours a day.
- We help you define the input requirements (customer needs), the potential design risks and help to plan the design verification and validation requirements.
- Your medical product may require preclinical (animal) studies, third-party standards assessment or even a clinical study.
- Your medical product may require customized software, qualified biomaterials, electrical safety testing, packaging and sterilization or various types of supporting technologies to meet your customer requirements.
- Where you need expert services and specialty skills, we tap into our network of seasoned contractors to help you get the job done right. We work to define the deliverable documentation that you need to demonstrate your product works as intended and is suitable for regulatory applications.
- Success for your new venture may require connections. You may need a business development advisor, introductions to investors or a “exit strategy” to pull together all the pieces. Start-up companies can find it difficult to know who to talk to and who to trust. We can help you take the worry out.
- For example, did you know that a contract manufacturer of a medical product must be registered with the FDA? Did you know that many materials used in medical devices can be purchased from suppliers who have already pre-qualified the material safety, which can save you tens of thousands of dollars?
With over thirty-years of experience in medical device technology, Paladin Medical knows how to get it done. From design to production, we can guide you through the process of selecting materials and contractors as well as meeting your medical development regulatory obligations.