This is a common question heard by consultants. While any consultant may not have direct experience with your particular device type, no consulting company will have experience with every device type. The submission process is the same regardless of device type (with a few exceptions), and understanding the FDA current thinking is more critical than experience with a particular device type. We can review your device and the regulatory requirements and see if DR-LLC is the right fit for your project.
Your product may be a medical device. The intended use of your device is a key driver of that determination. Even if your product is a device, it might be under enforcement discretion, or exempt from premarket authorization requirements. Let's talk and figure it out.
Yes DR-LLC can help with markets outside the US; not all markets, but some. At minimum, let's discuss your planned markets and some of the requirements to gaining access.
Start here! Send an email to DR-LLC and explain your situation. We will respond with some ideas about where to start and what is required as a medical device manufacturer.