Enhancing Regulatory Compliance and Product Quality: Designing a Robust Quality Management Implementation Plan in Alignment with ISO 13485 Standards

The primary aim of this capstone project is to conduct a comprehensive overview of Theradaptive’s quality systems and identify areas for enhancement to ensure compliance with both FDA and eventually ISO standards. Given the paramount importance of regulatory compliance in the medical device industry, the project will explore current literature on quality management and medical device regulation, scrutinizing the regulatory framework, quality system requirements, and best practices and common pitfalls governing the development, manufacturing, and marketing of these devices. Through this thorough analysis, the project aims to offer valuable insights and recommendations to enhance Theradaptive’s quality systems and reaffirm its dedication to delivering safe and effective medical therapeutics.