GrassrootsDx

Medical Device Regulatory Compliance, Made Practical.

Turn FDA and international regulatory requirements into actionable processes, technical documentation, and evidence with DIY Regulatory Kits, SOAR® training, and expert guidance.

Turn complex regulatory requirements into actionable development processes, technical documentation, and evidence for regulatory submission.

Grassroots Dx helps medical device innovators, software developers, and quality professionals navigate FDA and international regulatory requirements with practical DIY Regulatory Kits, SOAR® training, and expert guidance.


Our solutions combine structured frameworks, customizable templates, and regulatory education to help your team understand what is required, implement the right processes, and generate supporting evidence throughout product development.

FDA eSTAR | QMS ISO 13485 | IEC 62304 | SaMD | SiMD | Cybersecurity
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QMS

Build a Quality Management System That Works for Your Organization

Software

Build Regulatory Requirements Into Software Development

Cybersecurity

Build Cybersecurity Into Your Device From the Start

SOAR® Training

Understand the Requirements Behind the Work

How GrassrootsDx works

From Regulatory Requirements to Submission-Ready Evidence



Regulatory compliance requires more than knowing the rules or completing documents. Medical device teams must understand applicable requirements, implement processes, perform the necessary development activities, and generate evidence demonstrating the work performed.

GrassrootsDx connects these activities through a practical, four-step framework.

Learn

Understand What Is Required

Build regulatory knowledge through structured SOAR® training covering applicable FDA regulations, recognized consensus standards, guidance, and medical device development practices.

Implement

Put Regulatory Requirements Into Practice
Use customizable templates and structured frameworks to establish processes, define technical requirements, and integrate regulatory activities into product development.

Evidence

Document the Work as It Happens

Generate technical documentation, design records, risk management information, verification and validation evidence, and other applicable artifacts throughout development.

Prepare

Build a Stronger Foundation for Regulatory Submission

Organize the resulting evidence to support your Design History File (DHF), FDA eSTAR submission, and applicable international technical documentation requirements.

Don't wait until submission preparation to discover what your team should have been doing during development.

Featured Regulatory Kits

Practical tools for medical device teams

FDA Regulatory Training Built for Modern MedTech


  1. Teams Learn the regulations
  2. Understand the standards
  3. Apply the knowledge


Medical device software teams need more than general regulatory awareness. They need to understand how FDA requirements, recognized standards, and quality processes relate to the technical work they perform every day.

SOAR® bridges regulatory knowledge and modern development practices through structured, on-demand training developed for medical device software engineers, quality professionals, and regulatory teams.

Whether you're entering the medical device industry or strengthening your team's regulatory knowledge, SOAR® provides structured education to support development in a regulated environment.
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What You'll Find in SOAR®
  • On-demand courses covering key regulatory and software development topics.
  • 90 minute training modules available through the complete program.
  • Practical regulatory education addressing FDA regulations, EU requirements, IEC 62304, ISO 13485, risk management, cybersecurity, and Agile development.
  • Flexible learning options with individual courses or the complete training program.
  • Certificates of Completion for individual courses and the full program.

Need Help Choosing or Implementing the Right Solution?

Not every team starts at the same point. You may be establishing your first quality management system, preparing for an FDA submission, addressing software documentation gaps, or determining which regulatory requirements apply to your device.

Our team can help you understand the available Grassroots Dx resources and identify the right next step.

About GrassrootsDx

Built on Real-World Medical Device Experience

Part of BeanStock Ventures

Grassroots Dx is part of the BeanStock Ventures family of businesses, bringing practical regulatory knowledge, training, and implementation resources to medical device innovators.


Accessible Regulatory Knowledge

We developed Grassroots Dx to make specialized regulatory knowledge more accessible to the people responsible for designing, developing, testing, and documenting medical devices.


Real-World Expertise

Our resources draw on experience supporting medical device development, quality systems, software engineering, regulatory documentation, and submission preparation.


Practical Implementation

By combining structured frameworks, technical templates, education, and expert guidance, we help teams integrate regulatory requirements into their everyday development activities.


FREE REGULATORY RESOURCES

Start Building Your Regulatory Knowledge

Not sure where to begin?

Explore free educational resources designed to help medical device teams understand regulatory expectations, development requirements, and the documentation involved in bringing medical technology to market.

Learn about quality management systems, medical device software, cybersecurity, FDA submissions, and other topics relevant to regulated development.
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Learn. Implement. Generate Evidence. Prepare.

GrassrootsDx combines practical regulatory training, customizable templates, and implementation tools to help MedTech teams turn complex requirements into actionable processes and submission-ready documentation.