The emergence of Industry 4.0 technologies and the subsequent digital transformation necessitates a paradigm shift in quality management practices. This shift has led to the development of Quality 4.0, a nascent field with limited research on its application within specific industries, particularly the medical technology sector. This study aims to bridge this gap by establishing an instrument to assess the awareness and readiness for Quality 4.0 implementation among Malaysian medical technology companies. The research employed a three-phased approach. Phase 1 involved a comprehensive literature review to identify key factors influencing Quality 4.0 implementation readiness. In Phase 2, a survey instrument was developed based on the literature review. This instrument underwent rigorous validation by a panel of academic and industry experts before pilot testing. Phase 3 utilized the pilot study results and respondent feedback to refine the survey. Subsequently, the final instrument was administered to six case study organizations within the medical technology sector located in Johor, Malaysia. Data analysis of the field survey results assessed the current awareness and readiness levels of each organization, generating an "organizational score." These scores were then used to categorize the case studies into five distinct Quality 4.0 implementation readiness levels. This research contributes valuable insights into the current state of Quality 4.0 awareness and readiness within the Malaysian medical technology sector. The developed instrument offers a valuable tool for future research and practical applications, enabling medical technology companies to evaluate their own readiness for adopting Quality 4.0 practices.