Guided 510(k) Service

Accelerate Your Path to FDA Clearance

In the rapidly evolving landscape of medical device software, 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, ensuring that your innovative medical device software meet the stringent requirements set by the FDA and reach the market where it can help patients.

Unlike our “Fast 510(k)” service, where we rapidly write most of the documentation for your team, 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.

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:

• 2023 “Content of Premarket Submissions for Device Software Functions”
• 2023 “Off-The-Shelf Software Use in Medical Devices”
• 2023 “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

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.