Oct 22 • General discussion
Design Control, Golden Thread from Regulatory Requirements to Equipment Qualification
Welcome to QARAmate: Master Equipment Qualification & Process Validation for MDR Compliance 🚀
Are you navigating the complexities of Equipment Qualification and Process Validation for medical devices under the EU MDR? Feeling overwhelmed by the requirements, unsure where to start, or struggling to create that "golden thread" auditors demand?
In the newly added classroom, we cascade down in a simple and digestible manner what does the regulator requires, what does the auditor look for and how the equipment qualification and process validation can evidence and satisfy both the regulatory expectation and your auditor inquiries
The articles provide the roadmap, but the community is where the journey comes alive!
- 💬 Discuss & Clarify: Engage directly with Guillaume and fellow members. Ask questions about the articles, share your specific challenges, and get unstuck.
- 🎯 Get Audit Ready: Use the community and resources to prepare for internal or external audits with confidence. Learn what auditors really look for
- 📈 Elevate Your Quality Culture: Participate in discussions and access resources aimed at genuinely raising the quality mindset within your organization.
- 🧑🏫 Explore Training Opportunities: Be the first to know about focused training sessions or workshops based on the series and other critical RA/QA topics.
This isn't just another group – it's your dedicated space to transform Equipment Qualification and Process Validation from a regulatory burden into a strategic capability
Ready to master compliance and boost your manufacturing excellence?
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Design Control, Golden Thread from Regulatory Requirements to Equipment Qualification
