Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
The Compliance Control Program
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.
Program Details:
This training course is designed for RA/QA professionals working with medical devices and IVDs under MDR who want to modernize their documentation process and meet real audit expectations. Whether you're focused on Annex II files, Article 10.9, or PRRC responsibilities, this program gives you the tools to build a traceable, defensible system — powered by AI.
Whether you work with medical devices, in vitro diagnostics (IVDs), pharmaceuticals, or biotech products, this program will provide you with the tools and strategies you need to modernise your compliance workflows.
🔧 What You’ll Learn (Module Summary)
Module 1 – Structure Your Applicable Requirements
Define your product’s regulatory landscape and document what applies — with AI-assisted justification and a traceable version log.
📄 Output: Applicable Requirements Log with rationale
Module 2 – Justify Your Technical File
Turn those requirements into documented evidence. Generate structured, source-linked GSPR justifications and conformity statements.
📄 Output: Annex II-ready GSPR Report
Module 3 – Build Oversight and Defendability
Create PRRC-ready summaries, simulate audit Q&A, and prepare internal briefings that show how compliance decisions are tracked.
📄 Output: PRRC briefing + audit traceability pack
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Build What Matters: Compliance demands structure, justification, and oversight. This program helps you create documentation that’s audit-ready — not just theory.
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Hands-On, Not Fluff: You’ll use your own documentation, AI tools, and Hoodin’s Smart Compliance List to create real outputs: GSPR justifications, requirement logs, and PRRC briefings.
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Fits Your Schedule: With just 3 short modules (30–40 minutes each), the program is fully self-paced. No webinars. No scheduling. Instant access.
Details:
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Cost: 100% Free
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Duration: Self-paced (available during summer access period)
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Time Commitment: ~30–40 minutes per module (3 modules total)
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Mode: Online, on-demand – no live sessions
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Included: AI tool guidance, practical exercises, templates, and a certificate of completion
Don´t Miss Out!
Regulatory expectations are rising — and static documentation won’t cut it. This self-paced program shows you how to build audit-ready files using AI and real regulatory tools.
Join Now
Questions?
Visit the website for more information or support: 🌐 www.hoodin.com
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