198
Views
3
CrossRef citations to date
0
Altmetric
Innovation

Two-level process validation approach for medical devices

Pages 139-149 | Received 29 Mar 2019, Accepted 22 May 2019, Published online: 18 Jun 2019
 

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.

Disclosure statement

No potential conflict of interest was reported by the authors.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.