Top 10 Best Medical Device Qms Software of 2026

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies, streamlining compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR, and other regulations. It offers integrated modules for design controls, risk management (ISO 14971), CAPA, document control, audits, training, complaints, and supplier management. The software replaces spreadsheets and disjointed tools, enabling faster audits, reduced non-conformances, and accelerated product launches while maintaining traceability across the product lifecycle.

Qualio is a modern, cloud-based eQMS platform tailored for life sciences companies, particularly medical device manufacturers, to manage quality processes like document control, training, CAPA, complaints, audits, and supplier quality. It ensures compliance with ISO 13485, FDA 21 CFR Part 820, and other regulations through automated workflows, electronic signatures, and integrated reporting. Designed for scalability, it supports growing teams from startups to enterprises with a user-friendly interface that reduces administrative burden.

MasterControl is a robust enterprise Quality Management System (QMS) software designed specifically for regulated industries like medical devices, pharmaceuticals, and biotech. It provides integrated modules for document control, CAPA, training management, audit management, complaint handling, and supplier management to streamline compliance with FDA 21 CFR Part 11, ISO 13485, and other global standards. The platform emphasizes automation, electronic signatures, and real-time analytics to reduce manual errors and accelerate time-to-market for medical devices.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, tailored for regulated industries like medical devices to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other standards. It offers modules for CAPA, audits, complaints, non-conformances, document control, training, supplier management, and risk management, streamlining quality processes end-to-end. Leveraging Salesforce's scalability, it enables seamless integration with CRM for customer-centric quality management and no-code customization.

ETQ Reliance is a highly configurable enterprise quality management system (EQMS) designed for regulated industries, including medical devices, to streamline compliance with ISO 13485, FDA 21 CFR Part 820, and other standards. It offers modules for CAPA, audits, complaints, document control, supplier management, risk management, and training, all unified in a no-code platform. The software emphasizes workflow automation and real-time analytics to drive continuous improvement in quality processes.

Veeva QualityOne is a cloud-based Quality Management System (QMS) tailored for life sciences, including medical device manufacturers, offering end-to-end processes for quality events, CAPA, audits, complaints, training, and supplier management. It ensures compliance with ISO 13485, FDA 21 CFR Part 820, and other regulations through unified workflows and robust reporting. The platform integrates seamlessly with Veeva Vault for document control and leverages AI for predictive insights, enabling proactive quality improvements.

AssurX is a robust enterprise Quality Management System (QMS) software designed for regulated industries like medical devices, offering modules for CAPA, complaints handling, audits, document control, training, and supplier management. It ensures compliance with standards such as ISO 13485, FDA 21 CFR Part 11, and EU MDR through configurable workflows and automated processes. The platform provides real-time dashboards and reporting for quality metrics, enabling proactive risk management and continuous improvement in medical device manufacturing.

TrackWise Digital by Honeywell is a cloud-based Quality Management System (QMS) platform tailored for regulated industries, including medical device manufacturing, to manage processes like CAPA, complaints, audits, deviations, and supplier quality. It offers configurable workflows, AI-powered analytics, and real-time dashboards to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and other standards. The software emphasizes digital transformation with low-code configuration and integration capabilities for enterprise-scale operations.

SimplerQMS is a cloud-based eQMS platform tailored for medical device manufacturers and life sciences companies, offering robust document control, training management, CAPA, non-conformance handling, complaints, audits, and supplier management. It ensures compliance with ISO 13485, FDA 21 CFR Part 820 and 11, EU MDR/IVDR, and other regulations through electronic signatures, audit trails, and automated workflows. The software emphasizes simplicity with no-code configuration, enabling quick deployment without extensive IT support.

Ideagen Quality Management is a cloud-based QMS platform tailored for regulated industries like medical devices, offering modules for document control, CAPA, audits, risk management, training, and supplier quality. It ensures compliance with ISO 13485, FDA 21 CFR Part 11, and other standards through automated workflows, electronic signatures, and real-time reporting. The software provides end-to-end visibility into quality processes, supporting continuous improvement and scalability for growing organizations.