Regulatory Services

Regulatory Consulting

Innolitics staff has 20 years of experience in providing regulatory strategy, design documentation, and submissions for Software as a Medical Device (SaMD) and Software in Medical Devices (SiMD). We can help you make the correct choices to obtain timely and cost-effective market access in the United States, EU, UK, and Canada:

Software Regulatory Strategy

We can help you answer these types of software regulatory questions:

There are a lot of regulatory firms that know about the software regulations, but there are very few that know about the software regulations and also know about software. We can speak both languages and help get your device as quickly as possible.

Let's talk

We can help you hit your next milestone on time.

Phone: +1 (512) 967-6088


Calendly: schedule a call