Title: Development of a validation and qualification process for the manufacturing of medical devices: a case study based on cross-sector benchmarking

Authors: Yuchun Xu; Ashutosh Tiwari; Hao Chen Chen; Christopher J. Turner

Addresses: School of Aerospace, Transport, and Manufacturing, Cranfield University, Cranfield, Bedfordshire, MK43 0AL, UK ' School of Aerospace, Transport, and Manufacturing, Cranfield University, Cranfield, Bedfordshire, MK43 0AL, UK ' School of Aerospace, Transport, and Manufacturing, Cranfield University, Cranfield, Bedfordshire, MK43 0AL, UK ' School of Aerospace, Transport, and Manufacturing, Cranfield University, Cranfield, Bedfordshire, MK43 0AL, UK

Abstract: The validation stage plays a critical role in the development and production of medical devices; it ensures new medical devices meet all the functional, reliability and quality requirements of both customer and regulatory authorities. This paper presents a case study concerning validation and qualification process for medical devices in a UK-based medical device manufacturer. The work aims to develop an efficient and highly reliable procedure for the validation of medical devices. A benchmarking study has been performed to identify the best practices in product validation. The existing practices within the case study manufacturer have been reviewed to identify opportunities for validation improvement. New practices have been proposed for the case study manufacturer, and guidelines for implementing the proposed validation procedures have also been developed.

Keywords: medical device; quality control; validation; qualification; benchmarking.

DOI: 10.1504/IJPMB.2018.088658

International Journal of Process Management and Benchmarking, 2018 Vol.8 No.1, pp.79 - 102

Received: 29 Feb 2016
Accepted: 11 Jun 2016
Published online: 14 Dec 2017 *

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