We’re excited to announce that Ryden AI’s continuous gap analysis platform now supports the European Union Medical Device Regulation (EU MDR) QMS requirements — a major milestone that enhances our platform’s ability to help medical device manufacturers navigate complex regulatory environments with ease.
What is EU MDR and Why Does it Matter?
The EU Medical Device Regulation (Regulation (EU) 2017/745) came into full effect in May 2021, replacing the previous Medical Device Directive (MDD). With stricter requirements for clinical evaluation, post-market surveillance, risk management, and documentation, EU MDR poses a significant compliance challenge — especially for manufacturers with legacy products or complex portfolios.
Meeting EU MDR standards isn’t just about ticking boxes; it’s about demonstrating continuous safety, performance, and risk mitigation throughout a product’s lifecycle. That’s where Ryden comes in.
EU MDR Now a part of Ryden
We’ve integrated EU MDR requirements directly into the Ryden platform. This means:
- Automated identification of compliance gaps against EU MDR standards
- Continuous readiness for audits, with dynamic mapping to EU MDR Chapters and annexes
- Support for new submissions
- Instant audit reports structured in the format auditors expect
Making Submissions Simpler and Smarter
For new devices entering the EU market, Ryden now helps users align with EU MDR expectations from the very beginning. No more second-guessing what a notified body is looking for — Ryden provides real-time clarity and submission confidence that reduces both the effort and risk associated with bringing a product to market.
Stay Audit-Ready — Always
With Ryden, you’re no longer scrambling to prepare for audits. EU MDR’s emphasis on post-market surveillance, vigilance, and quality system oversight means that compliance is ongoing — not a one-time task. Our system keeps track of every update, every change, and every potential deviation, giving you:
- Proactive gap analysis when documentation or processes fall out of sync with EU MDR
- Audit simulations to test your readiness before a real inspection
- Evidence libraries mapped to EU MDR clauses, making it easy to retrieve and justify decisions
The Bottom Line: Peace of Mind
EU MDR has raised the bar, but with Ryden, staying compliant doesn’t have to be painful. Whether you’re preparing for your first EU submission or managing multiple devices across global markets, our platform now gives you the structure, intelligence, and automation you need to stay ahead.
Ready to see how EU MDR support can transform your compliance process? Book a demo today.
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