Digitalisation of the Quality Management System in the Medical Device Industry for Certification

Abstract

The Indian medical device manufacturing sector is rapidly growing yet faces persistent challenges related to regulatory compliance, limited access to advanced technologies, and economic constraints. These issues are particularly found among Micro, Small, and Medium Enterprises (MSMEs), which constitute a major portion of the industry in India. As the global manufacturing landscape shifts towards digitalisation under the Industry 4.0 (I4.0) paradigm, there is an urgent need for Indian manufacturers to adopt digital transformation strategies. This research investigates how digitalisation that too particularly through Quality 4.0 (Q4.0), can be effectively applied to the Quality Management System (QMS) implementation and auditing processes, which are crucial for obtaining medical device certification. The study begins with a systematic literature review and ground surveys to identify the core challenges faced by manufacturers and found challenges around QMS documentation. A detailed knowledge analysis reveals specific gaps and requirements in quality system documentation. To address these, Industry 4.0-based smart technological interventions were implemented in a selected factory setting. These included, implementing Internet of Things (IoT), data capture, and real-time monitoring systems. The impact of these interventions was measured through operational quality metrics, revealing a significant increase in First Pass Yield (FPY) and a marked reduction in rejection rates. These outcomes indicate improved quality control and process efficiency. Building on these insights, a comprehensive digital transformation conceptual framework called Smart Manufacturing Framework for Transition in Quality (SMaRT-Q) was developed. The framework enables organisations to systematically adopt smart manufacturing techniques for quality processes and its evidence data capture. Its effectiveness was evaluated using the Multi-Criteria Decision-Making (MCDM) method, specifically the Technique for Order Preference by Similarity to Ideal Solution (TOPSIS) applied on an electronic device assembly in a controlled environment. The analysis demonstrated superior performance of digitalized systems over conventional data capture methodologies. For operationalising SMaRT-Q with the QMS strategies, a modified Lean Six Sigma DMAIC approach integrated with Design of Experiments (DoE) was applied. This facilitated optimisation of critical quality parameters and better alignment of smart factory layers with the framework. Additionally, Key Performance Indices (KPIs) derived from digital systems were mapped to standard QMS clauses, ensuring regulatory compliance while automating evidence data collection. To support digital and online mode of auditing, the thesis introduces a novel maturity assessment model ie., Maturity Assessment of Digitalisation of QMS (MADQMS). An application was developed using MS Excel platform based on this model. The model defines five maturity levels based on readiness factors such as sensing, networking, decision-making, actuation, and documentation. A Delphi study involving practicing medical device industry auditors was conducted to validate the model. Feedback collected through a Likert-scale survey showed strong consensus on the applicability and usefulness of the model for auditing QMS in the era of Q4.0. In conclusion, this research provides a structured pathway for Indian medical device MSMEs to digitally transform their quality management practices. By integrating smart technologies and introducing maturity-based audit mechanisms, the study enables robust, data-driven documentation and improved certification preparedness in the medical device manufacturing sector.