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:
Innolitics has deep expertise in image processing and algorithm development. Our algorithms have been deployed in several FDA cleared applications and we can build your algorithm as part of a new device or to augment an existing device. Our competencies include:
If your software needs to interoperate with other software using the DICOM Standard, you will want a DICOM Conformance Statement. This document specifies the capabilities of your device in a standard format. Your customers will use it to evaluate whether your product can interoperate with their existing software.
DICOM Conformance Statements are dense technical documents. If nobody on your team has written one before, it will likely be faster to have a DICOM expert help you write one that you can confidently give to your customers.
We can help you write a statement within a week, but timelines will vary depending on the complexity of your software. Engagements start at $5k. (We can also help modify existing statements.)
Our team of engineers has significant experience working with the DICOM Standard. We wrote the DICOM Standard Browser, partly for our use. It is now the top site for many DICOM-related searches and is used by more than 10,000 engineers and radiologists each month.
Networked medical devices are becoming increasingly common, ranging from hardware, like patient monitoring equipment and infusion pumps, to pure Software as a Medical Devices (SaMD), such as web-based DICOM viewers. Connectivity often benefits patients and practitioners, but it introduces new cybersecurity risks.
Our cybersecurity team can help you develop secure connected devices that will keep patients safe. Not only can we help write documentation for premarket submissions, but we can also help you navigate buyer’s IT concerns once you want to start selling your device.
We provide the following services: