Bill Watson Are you looking for help in mapping out the process, or have you mapped out the process and need help executing? I can make an introduction for you, but I'd need to know your area of focus to best help.

Joachim Reinke Same question over here: where are you right now? Have you just discovered that what you are building will possibly be a medial product (that's usually the first) or have you already started figuring out what that means (i.e., reading norms, tracking their x-dependencies) or are you already at the 3rd level (having started to write down a QM system and ended in the middle of nowhere with the experience that this is something someone specialized in that area should do)?

Depending where you are different suggestions apply.

Eric Krohn thanks Bill, likely we would need help executing the process. likely our device is class 2.

Eric Krohn Thank you both,..well due to the UVC bulb it is certainly a medical device class II,...and it is meant for cleaning a used syringe. Going past this point is new territory as it appears this might not have a predicate device. And this is our first work in the medical device field.