Accelerate Your Path to FDA Clearance
Navigating the path to FDA 510(k) clearance can be daunting, especially for companies seeking clearance for their first product. Our "Guided 510(k)" service is designed to simplify this journey.
Unlike our Fast 510(k) solution, where we rapidly write most of the documentation for your team on a fixed-price basis, our Guided 510(k) is for teams that want to do most of the work themselves, but need training, templates, and document review support. We can tailor our engagements to meet your needs and budget.
We’ve Helped Others Like You
Our team has FDA cleared more than 50 SaMD and SiMD products.
Innolitics’ team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it’s a monumental milestone.
Amr Abodraiaa
CEO of Rology
Thanks to Innolitics, we were able to complete the software documentation for our 510(k) in just 4 months. They flew onsite to absorb how our software worked and provided detailed guidance. Without Medtech OS, training, and support, I can easily imagine the process taking 12 months. Our engineering team was able to focus on feature development instead of being bogged down with documentation. We tried three different consultants before finding Innolitics. None of them could deliver. Innolitics took the reins and made it happen. I don’t see how we would have completed our 510(k) without them.
VP of Systems R&D
IVD Startup
Our Specialized Services
Team Training and Guidance
We believe in empowering your team for not just the current submission but for future regulatory success. Our services include:
- Guided Walkthroughs: Navigating you through the 510(k) submission process with clarity and precision.
- Hands On Guidance: We don’t just give you templates, we provide concrete, specific examples and advice for your Engineers.
- Document Review: We can review your documentation for gaps.
- Determining “How Much is Enough”: With much of the FDA guidance, it is often difficult to know “how much is enough”. We’ve helped companies with their 510(k) clearance, so we can help you strike the right balance between complying with FDA’s expectations while not going out of business (and thus never bringing your technology to help patients).
Documentation Support
Understanding the critical role of documentation in the 510(k) process, we offer our suite of tried-and true SaMD templates that cover the latest FDA Guidance, including, but not limited to:
Cybersecurity Focus
With the FDA's increasing emphasis on cybersecurity, our service places a significant focus on ensuring your SaMD meets the FDA’s stringent of cybersecurity regulations. We provide in-depth guidance for all stages of the device's lifecycle, from design to post-market surveillance, including:
- Security Risk Management and Threat Modeling
- Cybersecurity Controls
- Cybersecurity Testing
- Postmarket Cybersecurity Processes
Why Choose Our Guided 510(k) Service?
- Dual Expertise: Our unique combination of software development and regulatory knowledge offers a comprehensive perspective that covers all bases of your 510(k) submission.
- Customized Support: From training sessions to document preparation, our services are tailored to meet your project's specific needs.
- Cybersecurity Emphasis: With a strong focus on cybersecurity, we ensure that your submission meets the latest FDA guidance, protecting your device and your end-users.
With our "Guided 510(k)" service, your first step into the medical device market is supported by experts who understand both the technology and the regulatory framework. Contact us today to learn how we can help your SaMD or SiMD achieve FDA 510(k) clearance, paving the way for your innovative solutions to make a meaningful impact in healthcare.
