Top 10 Best Medical Device Compliance Software of 2026

Greenlight Guru is a cloud-based eQMS platform purpose-built for medical device companies, enabling compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regulations. It offers integrated modules for document control, risk management (ISO 14971), CAPA, audits, training, and design controls with full traceability. The software streamlines quality processes, reduces audit preparation time, and supports faster time-to-market through automation and reporting.

MasterControl is a leading electronic quality management system (eQMS) tailored for medical device manufacturers and other regulated life sciences industries. It automates critical compliance processes such as document control, CAPA, nonconformance management, training tracking, audit management, and supplier controls to ensure adherence to FDA 21 CFR Part 11, ISO 13485, and EU MDR regulations. The platform provides robust validation tools, electronic signatures, and real-time reporting to streamline operations and reduce compliance risks.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for medical device and life sciences companies to manage compliance with standards like ISO 13485, FDA 21 CFR Part 820, and EU MDR. It provides tools for document control, training management, CAPA, non-conformances, audits, and supplier quality in a unified platform. The software emphasizes ease of implementation and scalability, allowing teams to go live in weeks rather than months.

ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built natively on the Salesforce platform, designed for regulated industries like medical devices to manage quality processes end-to-end. It covers critical compliance areas including CAPA, complaints, audits, non-conformances, document control, training, supplier management, and risk management, with built-in support for FDA 21 CFR Part 820/11, ISO 13485, and EU MDR/IVDR. The platform uses AI-driven automation and analytics to enhance predictive quality intelligence and streamline workflows.

ETQ Reliance is a configurable, cloud-based Quality Management System (QMS) tailored for regulated industries like medical devices, enabling compliance with ISO 13485, FDA 21 CFR Part 11, and other standards. It streamlines processes such as CAPA, audits, document control, supplier management, complaints, and training through no-code workflows and automation. The platform offers robust reporting, analytics, and integration capabilities to support enterprise-scale quality operations.

Dot Compliance is a cloud-based eQMS platform tailored for medical device companies to manage quality processes and ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and other regulations. It automates key workflows including document control, CAPA, audits, risk management, training, and supplier management. The software emphasizes ease of implementation with pre-configured templates, helping small to mid-sized firms achieve audit readiness quickly.

SimplerQMS is a cloud-based electronic Quality Management System (eQMS) tailored for medical device and life sciences companies, ensuring compliance with ISO 13485, FDA 21 CFR Part 11, EU MDR/IVDR, and other regulations. It provides modules for document control, CAPA, training management, audits, complaints, and change control, replacing paper-based processes with digital workflows, electronic signatures, and automated approvals. Hosted on Microsoft Azure, it offers robust security, audit trails, and integration with Microsoft 365 tools for seamless user adoption.

ValGenesis is a cloud-based digital validation platform tailored for life sciences, including medical device manufacturers, enabling fully paperless validation lifecycle management compliant with FDA 21 CFR Part 11, EU Annex 11, and other global regulations. It streamlines processes from risk assessment and protocol execution to reporting and audit trails using electronic signatures and real-time collaboration. The VLMS10 system reduces validation timelines by up to 70% while maintaining data integrity and traceability for design controls, process validation, and equipment qualification.

Ketryx is a cloud-based compliance engineering platform tailored for medical device companies, enabling end-to-end management of regulatory requirements, risk assessments, and product traceability across the lifecycle from design to post-market surveillance. It automates workflows for standards like ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Part 820, with features for change control, CAPA, and audits. The platform integrates with tools like Jira, GitHub, and Polarion, fostering collaboration between quality, regulatory, and engineering teams.

AssurX is a robust enterprise quality management system (QMS) software tailored for regulated industries like medical devices, offering tools for CAPA, complaints, audits, supplier management, and training to ensure compliance with FDA 21 CFR Part 11 and ISO 13485. It provides configurable workflows, real-time analytics, and integration capabilities to streamline quality processes and mitigate risks. The platform excels in unifying disparate quality functions into a single system, reducing silos and improving operational efficiency.