Regulatory watch, guides and thoughts
Articles, lessons learned and regulatory watch to help QARA teams move forward.
What Is the Required Frequency for Updating Technical Files in 2026 to Stay MDR-Compliant?
In 2026, what is the required frequency for updating technical files to stay compliant with MDR? Discover the triggering events and best practices for continuous compliance.
Read the article →Inconsistencies Between EUDAMED, CER, PSUR, and Technical Files: A Growing Risk in 2026
In 2026, inconsistencies between EUDAMED, CER, PSUR, and technical files pose an increasing risk for medical device manufacturers. Learn how to anticipate and address these discrepancies.
Read the article →EUDAMED in 2026: Concrete Obligations for Medical Device Manufacturers
In 2026, EUDAMED becomes mandatory for medical device manufacturers. What are the concrete obligations regarding traceability, consistency, and data updates?
Read the article →Health Data and Sovereignty: Why We Reject Non-European Clouds
Health data and sovereignty: why entrust your strategic documents to European clouds? GDPR, security, and local solutions explained.
Read the article →Automating Compliance: Benefits, Risks, and Limits in the Pharmaceutical Industry
Automating pharmaceutical compliance: saving time, reducing errors, and simplifying audits. But what are the limits of AI and automated tools?
Read the article →Our Commitment to a Sovereign Solution: Critical Dependency Revealed by Geopolitical Developments
Europe depends 90% on US cloud providers (AWS, Azure, GCP). The Cloud Act and security incidents threaten digital sovereignty. What solutions for the EU?
Read the article →L'ANSM face à l'infobésité santé : les réseaux sociaux et l'IA changent la donne
Polémiques, harcèlement, perte de confiance : l'IA et les réseaux sociaux bouleversent la communication santé. Quels défis pour l'ANSM et le secteur médical ?
Read the article →The Illusion of Transparency? What the Code of Practice on AI Does (and Doesn't) Change
In July 2025, the EU published a Code of Practice for general-purpose AI (GPAI) like ChatGPT. While it promotes transparency and safety, it remains voluntary. What does this mean for healthcare?
Read the article →AI Growing More Powerful... But Lowering Our Standards?
AI is revolutionizing intellectual production, but its proliferation threatens the quality of scientific and medical publications. What are the risks?
Read the article →Shadow AI: Balancing Invisible Risks and Strategic Governance
Shadow AI, used by 90% of employees, exposes companies to GDPR and cybersecurity risks. How can businesses effectively regulate this ghost AI?
Read the article →Reflecting on Our Time at EuraTechnologies
Since May 2025, Eryon has been incubated at EuraTechnologies. A key milestone for our project, our team, and our vision of entrepreneurship.
Read the article →Understanding the Requirements of the AI Act: How the Code of Conduct Impacts Developers and AI Integrators
Since the adoption of Regulation (EU) 2024/1689, AI stakeholders operating in Europe must comply with a strengthened legal framework. Discover the implications of the voluntary Code of Conduct for general-purpose AI models.
Read the article →The AI Act Explained for SMEs: Key Points to Prepare Effectively
The European Regulation on Artificial Intelligence (AI Act), which came into force in 2024, is the world's first major attempt to regulate AI systems. Discover the specific opportunities and obligations for SMEs.
Read the article →Trusting AI Without Losing Critical Thinking: Toward Intelligent and Sovereign Collaboration
AI is a powerful tool, but blind trust carries risks. Discover how to integrate AI into your processes while preserving your critical thinking and intellectual sovereignty.
Read the article →Why We Created Eryon: A Look Back at the Project's Origins
Discover the origins of Eryon, born from the hands-on experience of its founders to automate medical and regulatory review, combining sovereignty and performance.
Read the article →Data Sovereignty in the Face of the Cloud Act and GDPR
Discover how to protect the sovereignty of health data against the Cloud Act and GDPR. Sovereign solutions with Eryon for compliance and security of sensitive data.
Read the article →Our latest posts
A selection of our LinkedIn posts on compliance, sovereignty and AI in healthcare.
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A digest of regulatory changes, the articles we write, and the team's events.