LARS Program
Building an Audit-Ready Justification Record
How to Demonstrate Compliance, Map Evidence, and Defend Annex II/III
December 9, 11AM CET (45 MIN)
The justification record is one of the most scrutinised elements in technical documentation. Many teams struggle to articulate how each requirement is met, where the supporting evidence sits, and how this aligns with Annex II/III expectations. This session provides a structured, defensible approach to building a justification record that withstands auditor review.
Speakers
Marcus Emne
Chief Executive Officer at Hoodin
Creating Defensible, Audit-Ready Justifications
This session lays the foundation for the programme by showing how to transform a list of applicable requirements into a structured justification record that meets audit expectations and supports regulatory accountability.
You will learn to:
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Develop requirement-specific justifications that are clear, concise, and defensible
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Map each requirement to evidence, design documentation, conformity routes, and relevant Annex II/III sections
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Present compliance arguments in a form auditors can follow without interpretation
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Avoid common findings such as generic statements, incomplete traceability, and unclear rationale
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Maintain a version-controlled, audit-ready justification record using Hoodin
Free Online Training to Build Audit-Ready MDR Documentation with AI Support
A self-paced course for RA/QA professionals working with Article 10.9, Annex II, and PRRC responsibilities. No theory — just practical tools, real outputs, and immediate access.
The Compliance Control Program is a self-paced, AI-supported training course designed for RA/QA professionals who need to build audit-ready documentation aligned with MDR Article 10.9, Annex II, and PRRC requirements. Through three practical modules, you’ll learn how to structure your regulatory controls, generate justifications, and prepare for NB audits — using your real documentation, not templates.
In This Edition, You’ll Get Access To:
✅ AI-assisted training to structure and justify MDR documentation
✅ Step-by-step guidance across Article 10.9, Annex II, and PRRC tasks
✅ Hands-on exercises using your real documentation — no templates
✅ Tools like Hoodin and ChatGPT to accelerate traceability and reporting
✅ Instant access to 3 focused modules — no scheduling, no webinars
Limited Summer Access – Instant Access Available Now. 100% Free.