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.
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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