Starting a medtech company isn't easy and getting a novel device through the FDA's approval process is challenging. Get off to the right start with MedTech Impact Partners by adding our pres-submission package to your strategy of getting your device to market faster.

Milestones are important and that’s why we are thrilled to celebrate five years at MedTech Impact Partners! We couldn’t have grown to this point without the wonderful support of our global network of partners and outstanding clients.

What are the Special Considerations for Software as a Medical Device (SaMD)?

Software not only needs Food and Drug Administration (FDA) review if it is used as a medical device, there are also a set of guidances and policies unique to software for consideration. While getting software innovations approved by the FDA can be daunting, it is not impossible.