Luiza Almeida

The European Commission has launched a public consultation to reinforce its “Apply AI Strategy – Strengthening the AI Continent”. This initiative is aligned with the forthcoming implementation of the AI Act and aims to guide Europe’s position as a global leader in trustworthy, secure, and human-centric artificial intelligence. The strategy seeks to identify actions to: This is a strategic opportunity for stakeholders across industries — including healthtech, medtech, education, and manufacturing — to help shape the EU’s digital future. 📅 Deadline: 04 June 2025 📄 The Call for evidence is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.

📌 This comprehensive document highlights key common pitfalls that often delay assessments and provides essential recommendations to ensure your submissions are clear, consistent, and aligned with regulatory expectations. Good examples include: 🔍 Best practices for structuring documentation;🧩 Enhanced consistency and alignment across all documentation;🔗 Clear rationale for GSPR applicability and conformity demonstration strategy;📄 Insightful recommendations for risk management activities; 📂 Improved evidence management throughout the entire technical documentation. 👉 If you’re involved in regulatory compliance for medical devices, this is a must-read to streamline your certification journey and better collaborate with Notified Bodies. 📄 The full paper is available here. Let us know if this sounds interesting to you. I’d be happy to share more or schedule a quick call to explore how we can support your goals. Follow us on linked.in for regular updates.