Fast-Track your FDA Documentation for 510K

Build your QMS + DHF without starting from scratch

For MedTech teams preparing for FDA submission in the next 6–12 months
Built by FDA-accredited reviewers
Designed for 510(k) and De Novo submissions
Instant access
"Being our first time with true software product development, we appreciated that the DIY Software Kit integrated with our existing processes so that we did not need to migrate. We were able to reach more mature processes quickly."
     

Built for Teams Preparing for FDA Submission

  • Preparing for a 510(k), De Novo, or SaMD submission
  • Need a structured QMS + DHF without building from scratch
  • Want to move forward without hiring a full regulatory team
  • Need to clearly communicate safety and design to FDA reviewers
FDA submissions depend on how clearly safety and performance are documented, not just the data itself.

Most teams struggle with structuring this correctly from the start.


Write your awesome label here.

A Structured Starting Point for FDA Documentation

This FDA Starter Kit gives you the framework used to build submission-ready documentation aligned with FDA expectations.

  • 13 FDA eSTAR-ready templates
  • QMS and DHF framework
  • FDA submission training modules
  • Gap assessment and readiness guidance

Trusted by MedTech teams building toward FDA submission

Peter HOLMES, COO Barefoot Solutions
"The Software Architecture template was a massive time-saver for us. The document is comprehensive, clearly organized, and gave my team the guidance necessary to customize our document by emulating the original content structure"
Matthias Merten, Director, Resilience
"We chose DIY Regulatory Kits because it provided guidance and best practices to help us complete our SiMD/SaMD regulatory technical submission.

Being our first time with true software product development, we appreciated that the DIY Software Kit integrated with our existing processes so that we did not need to migrate. We were able to reach more mature processes quickly.”
Start Preparing for the FDA now!

Start building your FDA documentation with confidence.

Get immediate access to the FDA Starter Kit and begin structuring your QMS and DHF today.

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