Your medical device deserves a regulatory strategy of its own.

Just because your device is similar to one already on the US market, doesn't mean your regulatory needs are the same. Whether you are developing a new device, modifying an existing type, importing established devices, or looking to enter the US market with a product that has been successful elsewhere, you need a regulatory strategy that is tailored to your unique company position. Nu Device Consulting LLC can help. Whether your firm is in the US or not, we help get your medical device to market in the US and offer a range of services to handle your regulatory needs.

Services offered include:

• FDA 510(k) submissions (Class I and Class II)
• Help with RTA and AI requests
• Reimbursement strategy, including HCPCS Level II Coding verification and modification requests
• US Agent services
• FDA Registration and Listing