The medical device industry is highly regulated, where documented evidence of medical device manufacturing equipment qualification is a critical step to ensuring regulatory compliance, patient safety and device performance. This study undertook a comprehensive comparative analysis of paper-based and electronic-based equipment qualification (EQ) processes in the manufacturing of implantable orthopedic devices, assessed under the regulatory framework of the European Union Medical Device Regulation (MDR). The study critically evaluated the technological, regulatory, and operational impacts, with a particular emphasis on compliance, operational efficiency, and data integrity. The research was guided by the hypothesis that electronic-based EQ systems demonstrate superior capability in meeting the stringent regulatory requirements of the MDR, provide enhanced operational efficiencies, improve traceability, and documentation practices compared to traditional paper-based systems. A positivist philosophy, using a deductive approach, mono-method, quantitative research strategy in the form of a survey with a cross-sectional timeline, supported the aim of this research study. The survey/questionnaire was created using Microsoft Forms. The target audience were eligible participants with experience, either directly or indirectly, of paperbased and/or electronic-based EQ systems within the medical device industry. The survey was distributed via email and LinkedIn, a shortened URL link to the questionnaire was embedded within the invitation. The survey achieved 187 responses in total. The data was analysed using Minitab software application. The findings offered critical insights into the advantages and challenges associated with transitioning to or maintaining electronic-based EQ systems in highly regulated medical device manufacturing environments. Although the implementation of electronic systems requires upfront investment and training which can be seen as time-consuming, electronic systems significantly reduce major challenges such as human error. The transition from paper-based to electronic-based qualification systems has been overwhelmingly positive from a regulatory, operational, and quality standpoint. 74.43% of the participants agreed that technology has positively influenced the EQ process. The impact of the MDR has been felt to varying degrees across manufacturing facilities. Approximately 96% of the respondents reported no impact/positive impact on the EQ process since the introduction of the MDR. The study concluded that electronic-based EQ systems are not only justified but increasingly essential for manufacturers of implantable orthopedic devices within the European Union. Transitioning to electronic-based EQ systems optimises compliance and operational agility