We Speak Both Languages
Our team of software engineers and regulatory consultants have been helping medical device companies get onto the market since 2012.
Our Services
End-to-End Medical Device Software
We can help new Software as a Medical Device (SaMD) products get onto the market quickly and efficiently. Our team can work with you to identify the best regulatory pathway to market, design and develop the software, and make the premarket submission. We also provide on-going maintenance and consulting services once your device is on the market.
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Documentation for 510(k) Submissions
If you've nearly finished the development of your device but need to write the documents for your 510(k) submission, we can help. We can provide templates and self-help resources, consulting, or we can work with your engineers to draft the documents for your submission, all for a fixed-price using a proven process.
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Engineering Staff Augmentation
We can help your team meet an aggressive milestone. We can help with new feature development, refactoring of existing software, software verification and validation, and more.
Other Services
We also offer several other services, including:- Hourly Regulatory Consulting
- IEC 62304 Gap Analysis and Remediation
- Writing DICOM Conformance Statements
- Cybersecurity Penetration Testing
Why Innolitics?
Unlike less specialized software engineering teams, we move fast. We know IEC 62304 and the growing list of FDA Guidance. We also have regulatory experts on staff.
When you hire us, you hire the shared expertise of a talented team united by a shared mission to "accelerate progress in the medical device industry."
Testimonials
An investor once told me that it would take me $5 million and 5 years to get to where we are now. Innolitics got me here 3 years ahead of schedule and $4 million dollars under budget.
read more testimonialsInnolitics is an incredible partner and consistently surpasses our expectations. They have an extremely agile team, adapting to our needs across back-end and front-end tasks seamlessly. When we needed support around ISO 62304 compliance for FDA requirements, they jumped right in and provided us compliant documentation. They also assisted us as we developed a regulatory strategy around FDA Cybersecurity and HIPAA Compliance. The Innolitics team is efficient, fair, and highly ethical. They are an absolute pleasure to work with.
Tools & open-source
- Regulatory Documentation Manager
- MAUDE Alerts
- DICOM Standard Browser
- View My Scans
- FDA Browser
- all tools and open-source software
Popular articles
- A Technical and Regulatory Perspective on Generative Adversarial Networks in Medical Devices
- The FDA's 2018 Cybersecurity Guidance
- DICOM: The Purpose of the Standard
- Building an Image Classifier Using Pretrained Models With Keras
- A Brief Introduction to the United States Medical Software Regulations, for Developers
- Building a CT Slice Localizer With Keras
- Visualizing an Image Classification Model
- Deploying HIPAA-Compliant Software
- all articles our team has written
