Bring evidence-first gap analysis to your clients, or hire an expert partner when you want a second set of eyes.
Specialists we trust for high-stakes compliance, audit, security, and regulatory work.
PartnerMedical device + AI compliance across pre-market, post-market, and MDIS-enabled operations.
AI Gap Analysis finds evidence. MedQAIR consultants expand that into regulator-ready execution across SaMD/AI strategy, quality systems, economic-operator obligations, and post-market workflows.
PartnerRegulatory, quality, and clinical consulting for medical device + pharma teams.
Support across regulatory strategy, submissions, clinical, and quality systems for teams that need audit-ready documentation and clear execution.
Start with clause-by-clause evidence, source files, and page citations instead of hunting through PDFs.
Reuse evidence across ISO 13485, ISO 27001, ISO 9001, MDR, and custom requirements.
Partners validate findings, challenge weak evidence, and decide what should be delivered.
Security and privacy are designed for regulated documents, workspace isolation, and evidence ownership.
AI speeds evidence discovery and drafting, but it does not replace professional judgment or regulatory advice.
A simple engagement model that keeps evidence discovery, validation, and delivery in the right hands.
Client runs Outwrit or the partner runs it on their behalf.
Partner reviews findings and identifies what matters.
Audit-ready evidence, judgment, and a clear remediation plan.
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If you are a compliance consultant, auditor, regulatory or quality specialist, we can list you here and route the right prospects your way when we see a fit.
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