Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745
📌 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.