📌 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.
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