The “ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice” has been published.
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
What does this mean to you?
This standard identifies the principles that underpin clinical performance studies for IVDs, to ensure the conduct of the clinical performance study will lead to reliable and robust study results. It is highly advisable to adhere to this standard for all your clinical performance studies.
Clinical performance studies organised by Qarad are conducted in accordance to the requirements laid down in the ISO 20916:2019 standard.
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