Two-level process validation approach for medical devices

Abstract

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.

Keywords:

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

Disclosure statement

No potential conflict of interest was reported by the authors.