LARS Program
What Article 10.9 & ISO 13485 §4.1.3 Actually Require
Turn regulatory requirements into a living, traceable system. Learn how RA/QA teams can create a List of Applicable Regulations and Standards (LARS) to structure relevant requirements for their products — and how each requirement can be linked to a product-specific, auditable rationale to maintain control and demonstrate compliance.
November 11, 4:00 PM CET | 10:00 AM ET
Speakers
Marcus Emne
CEO
Hoodin
Turn regulatory requirements into a living, traceable system
In this session, we’ll break down what MDR Article 10.9 and ISO 13485 §4.1.3 actually require for maintaining regulatory compliance and oversight — and show how to build a List of Applicable Regulations and Standards (LARS) that proves it.
You'll also learn how to:
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Structure and justify applicable regulatory requirements for your products
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Demonstrate traceability and version control for audits
Whether you're part of the LARS-program or joining live for the first time, you'll see practical ways to strengthen compliance control and align your documentation with both MDR and ISO 13485.
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.