When most people think about FDA clearance, they often picture paperwork and a lengthy approvals process–complete with clinical data and guidance documents. While these facets of FDA approval for medical devices are crucial, there are some measures that can expedite the process. Minnetronix, in particular, secures FDA approval with careful design.
Designing for Medical Device Regulations
It can be easy for regulations to be relegated to the end of the design process. Many medical device manufacturers fail to account for FDA requirements early in the process and must scramble to alter their product right before production. These efforts to minimally alter the function of the device, while adhering to regulations, can result in unforeseen costs, labor, and coordination. One of the best ways how to get approval for medical devices is to design with FDA clearance in mind.
Priorities for Medical Equipment Manufacturers
Minnetronix understands that a medical device has some priorities that take precedence over others. Any medical device company will emphasize three characteristics for their product, without wanting to make sacrifices:
- Usability – Medical devices need to be usable, without compromise. FDA regulations won’t have a heavy effect on a product if it’s unusable. Some designers, however, struggle to emphasize a product’s usability while accommodating FDA clearance.
- Function – Function is everything for a medical device. When FDA guidelines force you to make changes to your product, it can be difficult to preserve the function of your product.
- Performance – Your organization will have clear goals for the performance of your product. Altering the performance level of your device should not be the solution for getting FDA approval for medical devices.
Relying on Minnetronix for FDA Clearance
For full lifecycle solutions, you can rely on Minnetronix. These full lifecycle solutions include our expertise in design and development. You can rely on our skilled teams of engineers and scientists to help you build a product that’s maximized for usability, function, and performance. In addition to design that adheres to FDA regulations, your final design will also allow for efficient manufacturing. To get started, and accelerate your next breakthrough, contact Minnetronix for more information.