Strategy for First-in-Human Studies (2/2) – MedTech CRO: Strategy Development Series

Device Advice by RQM+

*This video is part of our educational video series on clinical trials. Clips will cover three key areas: clinical trial strategy, clinical trial execution, and regulatory expertise in clinical trials. Please ⁠reach out to RQM+⁠ if you need support with clinical trials.*

❓ What are the CGMP principles and traceability requirements for 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗵𝘂𝗺𝗮𝗻 𝘀𝘁𝘂𝗱𝗶𝗲𝘀? How do you manage device iterations and site selection effectively?

🎬 The second video in our 𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝗖𝗥𝗢: 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗦𝗲𝗿𝗶𝗲𝘀 – 𝗦𝘁𝗿𝗮𝘁𝗲𝗴𝘆 𝗳𝗼𝗿 𝗙𝗶𝗿𝘀𝘁-𝗶𝗻-𝗛𝘂𝗺𝗮𝗻 𝗦𝘁𝘂𝗱𝗶𝗲𝘀 (𝟮/𝟮) answers these questions. Once again, Jaishankar Kutty, Ph.D. is back with VP of Strategic Regulatory Affairs Sew-Wah Tay.

𝗪𝗮𝘁𝗰𝗵 𝘁𝗼 𝗹𝗲𝗮𝗿𝗻:

📌 The importance of CGMP principles and full traceability for FIH devices

📌 Managing device iterations in a 10-15 patient FIH study

📌 Key considerations for site and physician selection across different geographies

We hope these strategies help you navigate the complexities of FIH studies and ensure success. RQM+ is here to help if you need it.

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