GrassrootsDx
Grow your medical device regulatory knowledge and connect with an
engaging community
What is GrassrootsDx?
The GrassrootsDx platform gives you the tools, insights, and updates you need to keep
your development on track and make real progress toward your medical device goals
Through expert-led training and proven templates, our innovative
platform provides a community of resources, empowering teams to:
Build regulatory knowledge
with collaboration & efficiency
Reduce learning curves with clear, actionable guidance
Fast-track their path to compliance and market readiness
What You Get
Cut through the complexity with clear, step-by-step guidance
Access DIY Regulatory Kits
Our DIY kits combine design templates, SOAR® training, and monthly Q&As to help you confidently fast-track your path to compliance.
Stay Informed, Supported, and Connected
Grow your regulatory knowledge with Ask Me Anything feeds, expert updates, templates, webinars—and connect with a community working on the same challenges you are.
Access DIY Regulatory Kits
This expert-led on-demand training program builds real-world regulatory skills while empowering teams to build regulatory knowledge and stay aligned without compromising compliance.
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Featured Case Study
Enterprise Speed Meets Clinical-Grade Standards: Rapid Deployment of a Custom Chemistry Data Platform
Read the full story: Enterprise Speed Meets Clinical-Grade Standards: Rapid Deployment of a Custom Chemistry Data PlatformSummary A Global Therapeutics Manufacturer needed a secure, scalable data portal to analyze and manage chemistry analyzer results across its internal teams. Though not FDA-regulated, the company required a platform with clinical-grade design rigor and rapid implementation. BeanStock Ventures deployed its customizable Bedrock framework, enabling the global therapeutics manufacturer to go from planning to production…
FDA-ready, engineer-friendly
Our (diy) Regulatory Kit equips early-stage teams with high-quality technical design templates required for your FDA eStar and EUMDR submissions, on-demand SOAR® training, and live Q&A support—saving you over $200K and 18 months in regulatory prep while keeping your medical device project on track
Expert Help From Start to Finish
A proven system to accelerate your time to market
Regulatory Strategy
Just beginning, or require clarity on your regulatory pathway? Start with our foundational regulatory strategy services to chart the most effective course to market readiness.
QMS & Technical Documentation Support
Ensure your QMS is in place and your DHF is complete with services like audits, assessments, design reviews, and documentation creation or updates.
FDA Submission Support
Navigate the entire FDA submission process with clear guidance on Q-Submission, eStar review or assembly, FDA additional information requests, or deficiencies.
Post-Market Support
After approval, get support with company and product registrations and ongoing compliance so your product stays current with FDA requirements.
Applying Our Expertise to
Your Unique Situation
With over 100 completed projects under our belt, we have the tools,
resources, and expertise to help you achieve your goals.
Let’s Build Your Path
to Approval
We’ll work with you to develop a clear plan that keeps things moving, helps you avoid delays, and gets your product ready for FDA approval.
We Have the Answers to
Your Top Questions
How do I ensure your templates meet all of the FDA requirements?
We are an accredited 3rd party review organization by the FDA, which means we understand exactly what the FDA is looking for and can help you focus on the most important details. We offer consulting and an FDA pre-submission audit, where we review your submission in advance and provide you with feedback to increase your chances of approval.
I already have a QMS Greenlight Guru or another eQMS. Do I need your help?
Your QMS might have all the processes you need, but does not come with DHF templates. You need both the process in place (internal and for future FDA audits) and the templates which are used to document your design which are submitted DIRECLTY to the FDA.
What happens at the end of the 12-month process?
At the end of the 12 months, you will have your DHF free and clear and can renew your training annually to meet FDA requirements.
I am looking to get clearance in another country. Can you help?
Our DHF templates meet all the requirements to satisfy both EU MDR and the FDA, if you use our templates, you will be ready for most markets and the US market.
Don’t see what you’re looking for? Reach out to our team