Research Use Only (RUO) vs. Device for Performance Study

Two persons in a research laboratory, viewing a computer screen

Zahra MavajianRegulatory affairs specialist – GBA Key2Compliance AB Disclaimer: This article is provided for informational purposes only and should not be considered official text. Always check and follow applicable local rules and regulations. Startups in the medical device or in vitro diagnostic (IVD) sectors often face challenges in obtaining regulatory approvals quickly, whether it be […]

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