New Guidance Alert for Medical Device Manufacturers!
The Medical Device Coordination Group (MDCG) has released the MDCG 2024-3 Guidance detailing the essential elements of a Clinical Investigation Plan (CIP) for medical devices. This comprehensive guide covers everything from the rationale and objectives to design methodology, monitoring, conduct, and analysis, ensuring you address all critical aspects of your clinical investigations.
Plus, don’t miss out on Appendix A: the Clinical Investigation Plan Synopsis Template, a practical checklist to streamline your planning process.
Remember, while this guidance is a valuable tool, it is not legally binding. Always ensure compliance with the MDR and ISO 14155 regulations.
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