Medical Device QMS (Quality Management System) A Medical Device Quality Management System (QMS) is a structured framework used by manufacturers to ensure medical devices consistently meet safety, performance, and regulatory requirements. It governs the entire product lifecycle—from design and development to production, distribution, and post-market surveillance. Medical Device QMS helps organizations comply with global regulations such as FDA 21 CFR Part 820, ISO 13485, and MDR. It ensures strict control over documentation, design controls, risk management, CAPA, supplier quality, and audit processes. By digitizing quality processes, modern systems reduce compliance risks, improve traceability, and enhance patient safety. Advanced platforms like ComplianceQuest enable automation, real-time visibility, and integrated quality workflows, helping medical device companies maintain continuous compliance and accelerate product innovation. https://www.compliancequest.com/quality/medical-device-quality-management-system/