What is it about?

Medical device industry encompasses a wide range of technologies and applications. Due to the diversity, medical device process validation guidance does not suggest a particular strategy and approach of validation implementation as that of pharmaceutical industry. Based on medical device manufacturing characteristics, and philosophies/principles of medical device/pharmaceutical industry process validation guidance documents, this article illustrates two-level process validation approach (IQ, OQ & PQ framework) which includes component production level and device assembly level. In addition, case study is provided to facilitate the understanding of how to utilize the process validation approach.

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Why is it important?

Th article can help medical device process validation practitioners to build IQ, OQ, PQ validation framework appropriately.


The article can help medical device process validation practitioners easily and correctly set up validation framework for any mechanical-based medical device manufacturing.

Yeong-Lin Chen

Read the Original

This page is a summary of: Two-level process validation approach for medical devices, Journal of Medical Engineering & Technology, February 2019, Taylor & Francis, DOI: 10.1080/03091902.2019.1626505.
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