Quality management of private label medical devices : a case study and conceptual framework from a European distribution division

Abstract

The medical device and healthcare industry is one of the most highly regulated sectors, with the European Medical Device Regulation (MDR [EU] 2017/745) fully coming into effect in May 2021. Due to the regulatory landscape and safety requirements for medical devices, organizations increasingly need to ensure robustness of their quality management systems to ensure product safety and regulatory compliance. Private label (PL) medical device companies face a unique situation, where under MDR Article 16 they often assume legal responsibilities of medical device manufacturers, while the business model revolves around the outsourcing of design, development, and production of products. Despite this, limited research and guidance exist on how private label companies can develop and manage a compliant and effective quality management system (QMS) in relation to their unique regulatory standing.

This thesis investigates the mentioned challenges through a single-case study of a European medical device distribution divisions (X division) private label operations, with the aim of identifying gaps in the current QMS and developing a conceptual framework to inform private label QMS design. The study incorporates a triangulated methodology including semi-structured interviews, a maturity assessment model, gap analysis based on ISO 9001:2015, ISO 13485:2016, and MDR 2017/745, and a SWOT analysis, with the mentioned methods being integrated with a regulatory, standards, and literature based theoretical framework.

Findings of the study identified several systematic inefficiencies between ABC’s operational responsibilities and manufacturer-level QMS practices, including undefined ownership of technical documentation, insufficiencies in supplier control, and limited QMS integration across X division’s subsidiary network. Based on the insights, the study proposes a QMS configuration where ABC is positioned as the operational quality owner of PL quality activities, original equipment manufacturer (OEM) reliance models are clarified, supplier agreements and cooperation are strengthened, complaint and vigilance handling are unified, and post-market surveillance processes are enhanced.

By addressing the apparent gap in empirical research, the study contributes a conceptual framework for PL QMS integration, balancing regulatory compliance, efficiency of operations, and organizational subsidiary coherence. Findings provide practical guidance for private label medical device companies for QMS alignment with MDR 2017/745, ISO 13485:2016, and ISO 9001:2015, while effectively leveraging OEM partnerships.