Medical Devices
Design a product to treat a medical condition.
Medical devices undergo a substantial amount of scrutiny by the FDA. There is a lot of paperwork and cost involved.
We can help choose the right regulatory path for your product.
Being strategic about treatment claims is very important.
Imprecise claims can put a device in a more stringent category.
We can help with design choices and identifying a predicate.
Get connected with an ISO-13485 manufacturer.
QMSR and General Controls are much easier to satisfy when going with an ISO certified manufacturer.
We function as a liaison with your manufacturer on your behalf.
We guide the process to ensure applicable standards are met.
Get brand-name quality with your product.
Our engineers have done research and product development with brand-name companies and this is the kind of quality you will get with your product.
Unique device authentication is done through certificates.
Access to devices, admins, and APIs require permissions.
Get assistance through market authorization.
There are ways that we can assist with 510(k) and PMA, such as producing test data, documentation, guidance from a design perspective, and, of course, the actual design and manufacturing of your product.
Get in touch
We'd love to hear from you! If you have any questions or are considering a product idea, feel free to reach out.