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  • Home
  • The 48-Hour FDA Readiness
  • Control Lens
  • blindspot
  • AI Integrated Control
  • Clinical Start Guide
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    • Control Audit
    • Control Accelerator
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    • Integrated Control Bundle
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Integrated Control Suite™ - Audit, Accelerator, Builder

Audit. Stress-Test. Rebuild.

The complete structural visibility system for MedTech control architecture.

$229 – Complete Suite Access

[ Get the Integrated Control Suite™ – $229 ]

  

Why a Suite?

Most organizations try to fix control gaps in isolation.

They run audits.
They react to findings.
They adjust documents.

But structural weakness is rarely isolated.

It is systemic.

The Integrated Control Suite™ delivers a full-cycle approach:

1️⃣ Identify fractures
2️⃣ Stress-test under inspection pressure
3️⃣ Rebuild structural continuity

This is not three downloads.
It is one engineered progression.

  

What’s Included

  

🧩 Integrated Control Audit™

Diagnose Structural Weakness

• Linkage assessment across Risk, Clinical, IEC 60601, CAPA, and Management Review
• Structural scoring matrix
• Continuity evaluation prompts
• Fracture identification summary

  

⚡ Integrated Control Accelerator™

Simulate Inspection Pressure

• Escalation scenario prompts
• Structural strain analysis
• Governance stress evaluation
• Vulnerability scoring worksheet

  

🏗 Integrated Control Builder™

Reconstruct Broken Control Loops

• Link restoration mapping tables
• Governance realignment prompts
• Control loop rebuilding worksheets
• Structural continuity confirmation page

  

Who This Is For

• Regulatory leaders
• Quality managers
• Engineering directors
• MedTech founders
• Organizations preparing for inspection
• Companies integrating AI into QMS architecture

  

Why This Matters

Inspection does not examine documents.

It examines continuity.

If Risk does not inform Clinical…
If Clinical does not inform CAPA…
If CAPA does not inform Management Review…
Control weakens.

This suite forces visibility across the full system.

  

Investment

Individual Purchase Total: $297

Integrated Control Suite™ Bundle: $229

Immediate digital access to all three structured instruments.


This is not a template bundle.

It is a structural architecture system.

[ Get the Integrated Control Suite™ – $229 ]


Used by regulatory and quality leaders preparing for high-stakes inspection environments.

  

Educational instruments. Not regulatory or legal advice.
For internal structural assessment and system alignment purposes only.


DocuRegs - Bridging Regulatory, Quality, and Engineering Through Integrated Control 

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