Build faster than the competitor

Regulatory compliance that scales with your product.

For Early-Stage Healthtech Founders

Get compliance right from the start.

Starting a healthtech company is exciting, but navigating the regulatory landscape shouldn’t hold you back. With Regulatory Navigator, you’ll get clear, actionable guidance on the regulations that apply to your product, without the cost of expensive consultants. Our AI-powered tool helps you make compliance decisions quickly so you can focus on growing your business.

  • Affordable & Fast: Skip the consultant calls and get answers on your terms.

  • Easy to Use: No regulatory experience needed—just follow the AI-powered guidance.

  • Tailored for Startups: Receive personalized insights and a step-by-step roadmap to stay compliant.

Ready to move faster?

Your Regulatory Team Deserves Better Tools

Regulatory teams are stuck maintaining traceability instead of building systems.
Your most experienced people are drowning in updates and formatting.

Every release becomes a documentation crisis.
Instead of focusing on clinical validation or market expansion, teams scramble to prove compliance again and again.

Small teams can’t scale manual processes.
Early-stage SaMD startups can’t afford to triple their headcount just to manage ISO.

Most tools weren’t built for how you actually work.
Legacy QMS systems are slow, rigid, and require weeks of onboarding. We’re different.

For Growing Healthtech Companies

Automate your compliance process as you scale.

As your company grows, so does the complexity of managing compliance. Compliance Automator streamlines the process, automatically generating audit-ready documentation and integrating seamlessly with your existing workflows. Say goodbye to manual documentation and focus on what really matters—scaling your business with confidence.

  • Automated & Scalable: Generate comprehensive, real-time documentation with ease.

  • Seamlessly Integrated: Works with the tools you’re already using, like Jira and Slack.

  • Confidence for Scaling: Stay compliant, even as your company expands.

Ready to automate compliance?

Stop rewriting the same ISO documents for every release.

  • Capture and document nonconformities as they happen — no manual tracking required.

    Our platform integrates with Jira and Slack to generate structured, compliant records into Notion, Google doc, Word, including:

    • Issue detection and categorization

    • Root cause and corrective actions

    • Linked evidence and resolution history

    • Audit-ready nonconformity logs

    • Ongoing status tracking

    Stay inspection-ready without relying on spreadsheets or missed follow-ups.

  • Generate audit-ready documentation for every release — without manual effort.

    We turn product data from Jira, Slack, and GitHub into structured ISO 13485 outputs, including:

    • Requirements traceability

    • Risk analysis and mitigation tracking

    • Verification & validation documentation

    • Change impact reports

    • Nonconformity records

    Stay compliant as you scale — no spreadsheets required.

  • Streamline your path to ISO 27001 with real-time documentation pulled from your existing workflows.

    Our platform transforms scattered evidence into structured outputs, including:

    • Security control mapping

    • Access and encryption documentation

    • Incident response tracking

    • Audit-ready reports

    • Continuous change monitoring

    Maintain trust and pass audits without adding manual overhead.

Why we built this

After years of battling the chaos of documentation black holes, messy project handovers, and the nightmare of reverse-engineering someone’s half-forgotten masterpiece, we knew something had to change. That’s why we built this product, to rescue teams from the trap of low-value busywork and give them the freedom to focus on creativity and innovation. Our mission? To help teams launch well-documented, safe products with ease, and even save you money along the way. Learn more

Contact Us

Interested in building with us? Fill out some info and we will be in touch shortly. We can’t wait to hear from you!