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J Med Eng Technol. 2019 Feb;43(2):139-149. doi: 10.1080/03091902.2019.1626505. Epub 2019 Jun 18.

Two-level process validation approach for medical devices.

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a Validation Department , SHL Group , Taoyuan , Taiwan.


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 which includes component production level and device assembly level. In addition, case study is provided to facilitate the understanding of how to utilise the process validation approach.


Medical device process validation; case study; equipment validation IQ/OQ/PQ; process validation PQ; two-level process validation

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