Nano Safe Coatings provides you a variety of services that will help expedite the FDA 510(k) process. In addition to providing qualified companies access to our FDA Device Master File (DMF), we also offer the following:
- An authorized officer from your company and from Nano Safe Coatings must sign a Non-Disclosure Agreement.
- Proof Of Concept: After agreeing on the items to be coated, you can send them to Ryerson University in Toronto, Canada to be treated with Nano Safe Coatings. In most cases the devices and products are returned to you to perform microbial and compatibility testing. Otherwise, the items are sent to an agreed upon third-party lab for testing.
- Testing Labs: If you do not have microbial testing capabilities in-house, we can furnish a list of qualified labs to perform the tests and provide you the results.
- Data and Information: To learn more about our technology, we have a large repository of data and information that is available on a case-by-case basis.
- Product Staging: We can assist you with the product staging process from beginning to end.
- Lab Capabilities: In addition to applying the coating to various substrates, Ryerson University has a fully equipped lab that can perform a variety of tests and procedures on a contract basis.
- Business & Marketing: Based on years of experience in the field of antimicrobials, the Nano Safe Coatings team can help you develop a marketing plan that will differentiate your products in the marketplace, and will meet your company’s sales and business objectives.
- Commercialization: Using our FDA Device Master File, we will work with you to commercialize the devices and products that are treated with our technology. We will work side-by-side to help ensure an expedited 510(k) process, and support a pathway and timeline to commercialization.