Regulatory readiness that passes audit — not paperwork theater.
Quality system design, regulatory documentation, and audit preparation for medical device and regulated industries.
Your quality system is a maze of documents that nobody reads. Audits are stressful. You are not sure if you are compliant or just lucky. You need someone who has run a quality organization, been through audits, and can build a system that works — not just one that passes.
I help regulated organizations build quality systems that are both compliant and usable. I served as Director of Global Quality at SonoSite, managed P&L for the quality organization, and have been through FDA and notified body audits. I know what auditors look for and I know how to build systems that your team will actually use.
Quality system gap analysis
Remediation plan prioritized by risk
Updated SOPs and work instructions for critical processes
Audit preparation package
Training plan for quality system users
Scope, regulatory framework, and current state determine the price. Fixed fee proposed after gap analysis.
How it works
Gap analysis
Review your current quality system against applicable standards and identify the gaps that matter.
Prioritize by risk
Sort the gaps by regulatory risk and business impact — fix what matters first.
Build the fixes
Update procedures, create missing documentation, and train your team on the changes.
Audit readiness
Mock audit, final corrections, and a system your team can maintain.
Why this matters
Quality system built by a former Director of Global Quality
Documentation that your team will actually follow
Audit readiness without last-minute panic
Reduced regulatory risk without unnecessary overhead
Domains we have worked in
Ready to get started?
Tell us what you need. We will tell you if it is a fit and what happens next.
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