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  • More
    • home
    • nice to meet you
    • what we do
      • regulatory affairs
      • quality management system
      • audit services
      • retained services
      • training services
      • tools made for QA/RA
    • בלוג
    • let's be in touch
  • home
  • nice to meet you
  • what we do
    • regulatory affairs
    • quality management system
    • audit services
    • retained services
    • training services
    • tools made for QA/RA
  • בלוג
  • let's be in touch

practical QA/RA tools for medical device teams

Hands-on tools built from real audit findings, regulatory work, and day-to-day quality management - not theory. 

  • Built by a medical device QA/RA expert with 20+ years hands-on experience
  • Based on real audits, inspections, and remediation projects
  • Designed to support daily work - not just documentation

the tools

quality navigator

quality.navigator - Interactive guidance for real QA/RA situations.

quality.navigator is a practical decision-support tool that helps QA/RA professionals think through everyday quality situations -complaints, CAPA judgment calls, nonconforming product, audit prep, risk decisions, and more.

Good for QA managers, RA professionals, startup teams and consultants.

Use it when you need clarity, structure, or a second professional lens before acting.

take me to quality.navigator

more to come

I'm currently working on more tools for you

wait for it...

more to come

I'm currently working on more tools for you

wait for it...

After years of audits, CAPAs, design reviews, and “can you just look at this for a minute” conversations - I realized most quality work happens between procedures. These tools are built for exactly those moments. 

These tools don’t replace consulting. They support it.

If a tool raises questions, gaps, or decisions you’re unsure about, that’s usually the right time to involve an experienced QA/RA partner.

talk to me

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