Confidently implement current Requirements, Guidelines and Best Practices
Clinical evaluation and clinical evidence are at the heart of every MDR-compliant marketing authorization and the maintenance of compliance. At the same time, regulatory expectations, guidelines, and review practices are constantly evolving. In this training, we’ll bring you and your team up to speed on clinical affairs – from changes in guidelines and standards to requirements of Notified Bodies, all the way to practical strategies for clinical trials, CERs, PMCF and label claims.
You will deepen your existing knowledge and learn to evaluate updates in a structured manner, integrate them into existing processes, and ensure the robustness of your clinical evidence throughout the product lifecycle.
- Content
- Regulatory Framework and current Developments
- Clinical Evaluation (CER) – State of the Art
- PMCF in Practice
- ISO 14155 & Study Conduct
- MDR Article 7 & Claims Compliance
- Lifecycle Management & Dossier Maintenance
- Audit & Notified Body Readiness
- Your Benefits
- You’ll gain a concise overview of the current requirements and expectations for Clinical Affairs under the MDR.
- You’ll be able to align CERs, clinical trials, PMCF, and claims in a consistent manner and support your arguments with evidence.
- You’ll be ready for audits and regulatory reviews, with robust justifications and a clear document structure.
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Clinical Affairs, Regulatory Affairs, Quality Management / QA
- Medical Writing, Labeling & Marketing in regulated environments
- Product Managers, Project Managers, R&D with a clinical interface
- Medical device manufacturers (all risk classes)
