Top 10 Best Medical Device Regulatory Compliance Software of 2026

Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) purpose-built for medical device companies to streamline regulatory compliance with FDA 21 CFR Part 820, ISO 13485, EU MDR/IVDR, and other standards. It provides integrated tools for document control, design controls, CAPA, risk management (ISO 14971), audits, training, and change management, all with pre-configured medtech-specific templates and workflows. The platform ensures traceability, audit readiness, and collaboration, helping teams reduce manual work and accelerate product launches.

MasterControl is a comprehensive electronic Quality Management System (eQMS) tailored for medical device manufacturers and other regulated life sciences industries to streamline compliance with FDA 21 CFR Part 11, ISO 13485, and EU MDR requirements. It provides integrated modules for document control, CAPA, audit management, training, non-conformance reporting, and supplier quality, automating workflows to reduce compliance risks and improve efficiency. The platform supports both cloud and on-premise deployments, with strong validation tools and connectivity to manufacturing execution systems.

Qualio is a cloud-based electronic Quality Management System (eQMS) designed specifically for medical device, biotech, and pharma companies to streamline regulatory compliance. It provides end-to-end management of documents, CAPA, non-conformances, audits, training, complaints, and supplier quality, ensuring adherence to ISO 13485, FDA 21 CFR Part 820, and Part 11. The platform features pre-validated workflows, automation, and integrations to reduce manual effort and accelerate time-to-compliance for growing life sciences firms.

ComplianceQuest is a cloud-based eQMS platform built on Salesforce, tailored for medical device manufacturers to manage regulatory compliance including CAPA, complaints, audits, document control, risk management, and training. It ensures adherence to FDA 21 CFR Part 11, 820, ISO 13485, and other standards through automated workflows, electronic signatures, and traceability. The software leverages Salesforce's scalability for enterprise-level deployment with real-time reporting and AI-driven insights.

ETQ Reliance is a comprehensive Enterprise Quality Management System (eQMS) platform tailored for medical device manufacturers to manage regulatory compliance under standards like ISO 13485, FDA 21 CFR Part 820, and Part 11. It provides configurable modules for CAPA, audits, complaints, document control, risk management, and supplier quality, automating workflows to reduce non-conformances and ensure traceability. The cloud-based solution emphasizes no-code customization, enabling organizations to adapt processes without developer intervention.

ValGenesis is a cloud-based digital validation platform tailored for life sciences, including medical device manufacturers, providing paperless validation lifecycle management to ensure regulatory compliance. It streamlines processes like risk-based validation, change control, deviation management, and audit trails, supporting standards such as 21 CFR Part 11, Part 820, and ISO 13485. The software eliminates paper documentation, accelerates validation timelines by up to 75%, and offers pre-configured templates for efficient deployment.

AssurX is an enterprise-grade quality management system (eQMS) tailored for regulated industries like medical devices, offering tools for CAPA, complaint handling, audit management, document control, and risk assessment to ensure compliance with FDA 21 CFR Part 11, ISO 13485, and EU MDR. Its no-code configuration platform allows users to customize workflows, processes, and dashboards without programming. The software provides robust analytics and reporting to drive continuous improvement and regulatory readiness.

SimplerQMS is a cloud-based electronic Quality Management System (eQMS) designed specifically for life sciences companies, including medical device manufacturers, to manage regulatory compliance processes. It provides out-of-the-box modules for document control, CAPA, change management, audits, training, and complaints handling, ensuring adherence to standards like ISO 13485, 21 CFR Part 11, EU MDR, and FDA 21 CFR Part 820. The platform emphasizes simplicity with pre-configured workflows, reducing setup time and customization needs for regulated environments.

TrackWise is an enterprise quality management system (EQMS) from Honeywell designed for regulated industries like medical devices, pharmaceuticals, and biotech. It streamlines compliance processes including CAPA, complaints, audits, training, and document control to meet standards such as FDA 21 CFR Part 11, ISO 13485, and EU MDR. With configurable workflows, electronic signatures, and robust reporting, it ensures audit readiness and traceability across the product lifecycle.

Kneat is a cloud-based Quality Management System (QMS) specialized in digital validation and compliance for life sciences, including medical device manufacturers. It streamlines the entire validation lifecycle from planning and risk assessment to test execution, approvals, and reporting, ensuring adherence to regulations like FDA 21 CFR Part 11, EU MDR/IVDR, and ISO 13485. The platform provides paperless workflows, electronic signatures, and comprehensive audit trails to reduce validation time and enhance efficiency.