Quick Overview
- 1#1: Greenlight Guru - Cloud-based eQMS designed specifically for medical device companies to manage ISO 13485 compliance, design controls, and risk management.
- 2#2: MasterControl - Comprehensive QMS platform for life sciences with robust document control, CAPA, and audit management supporting ISO 13485 requirements.
- 3#3: Qualio - Modern eQMS for life sciences startups and scale-ups, streamlining ISO 13485 processes like training, complaints, and quality events.
- 4#4: ComplianceQuest - Salesforce-powered QMS offering end-to-end ISO 13485 compliance with modules for document management, supplier quality, and audits.
- 5#5: ETQ Reliance - Flexible enterprise QMS with AI-driven insights for ISO 13485, focusing on CAPA, complaints, and continuous improvement.
- 6#6: SimplerQMS - Cloud QMS tailored for life sciences with strong document control and collaboration features for ISO 13485 certification.
- 7#7: Dot Compliance - No-code eQMS platform enabling customizable workflows for ISO 13485 compliance in medical device quality management.
- 8#8: ValGenesis - Digital validation and QMS solution for paperless ISO 13485 processes, including electronic signatures and audit trails.
- 9#9: AssurX - Integrated QMS for quality events, regulatory compliance, and risk management aligned with ISO 13485 standards.
- 10#10: Ideagen Quality Management - Suite of quality tools for document control, audits, and CAPA to support ISO 13485 in regulated industries.
Tools were chosen based on alignment with ISO 13485 requirements, feature depth (including document control, CAPA, and audit management), user experience, and overall value, ensuring they meet the diverse needs of medical device firms.
Comparison Table
ISO 13485 compliance is critical for medical device development, and this comparison table evaluates leading software tools like Greenlight Guru, MasterControl, Qualio, ComplianceQuest, ETQ Reliance, and more, helping readers understand their features, strengths, and suitability for streamlining quality management processes.
| # | Tool | Category | Overall | Features | Ease of Use | Value |
|---|---|---|---|---|---|---|
| 1 | Greenlight Guru Cloud-based eQMS designed specifically for medical device companies to manage ISO 13485 compliance, design controls, and risk management. | specialized | 9.7/10 | 9.9/10 | 9.2/10 | 9.4/10 |
| 2 | MasterControl Comprehensive QMS platform for life sciences with robust document control, CAPA, and audit management supporting ISO 13485 requirements. | enterprise | 9.1/10 | 9.6/10 | 7.8/10 | 8.4/10 |
| 3 | Qualio Modern eQMS for life sciences startups and scale-ups, streamlining ISO 13485 processes like training, complaints, and quality events. | specialized | 8.7/10 | 9.2/10 | 8.5/10 | 8.0/10 |
| 4 | ComplianceQuest Salesforce-powered QMS offering end-to-end ISO 13485 compliance with modules for document management, supplier quality, and audits. | enterprise | 8.6/10 | 9.2/10 | 7.9/10 | 8.1/10 |
| 5 | ETQ Reliance Flexible enterprise QMS with AI-driven insights for ISO 13485, focusing on CAPA, complaints, and continuous improvement. | enterprise | 8.4/10 | 9.1/10 | 7.6/10 | 7.9/10 |
| 6 | SimplerQMS Cloud QMS tailored for life sciences with strong document control and collaboration features for ISO 13485 certification. | specialized | 8.2/10 | 8.7/10 | 8.0/10 | 7.6/10 |
| 7 | Dot Compliance No-code eQMS platform enabling customizable workflows for ISO 13485 compliance in medical device quality management. | specialized | 8.1/10 | 8.6/10 | 7.9/10 | 7.6/10 |
| 8 | ValGenesis Digital validation and QMS solution for paperless ISO 13485 processes, including electronic signatures and audit trails. | specialized | 8.2/10 | 8.7/10 | 7.6/10 | 7.9/10 |
| 9 | AssurX Integrated QMS for quality events, regulatory compliance, and risk management aligned with ISO 13485 standards. | enterprise | 8.2/10 | 9.1/10 | 7.4/10 | 7.8/10 |
| 10 | Ideagen Quality Management Suite of quality tools for document control, audits, and CAPA to support ISO 13485 in regulated industries. | enterprise | 7.8/10 | 8.5/10 | 7.0/10 | 7.4/10 |
Cloud-based eQMS designed specifically for medical device companies to manage ISO 13485 compliance, design controls, and risk management.
Comprehensive QMS platform for life sciences with robust document control, CAPA, and audit management supporting ISO 13485 requirements.
Modern eQMS for life sciences startups and scale-ups, streamlining ISO 13485 processes like training, complaints, and quality events.
Salesforce-powered QMS offering end-to-end ISO 13485 compliance with modules for document management, supplier quality, and audits.
Flexible enterprise QMS with AI-driven insights for ISO 13485, focusing on CAPA, complaints, and continuous improvement.
Cloud QMS tailored for life sciences with strong document control and collaboration features for ISO 13485 certification.
No-code eQMS platform enabling customizable workflows for ISO 13485 compliance in medical device quality management.
Digital validation and QMS solution for paperless ISO 13485 processes, including electronic signatures and audit trails.
Integrated QMS for quality events, regulatory compliance, and risk management aligned with ISO 13485 standards.
Suite of quality tools for document control, audits, and CAPA to support ISO 13485 in regulated industries.
Greenlight Guru
specializedCloud-based eQMS designed specifically for medical device companies to manage ISO 13485 compliance, design controls, and risk management.
MedTech-native architecture with built-in ISO 13485 templates and seamless risk-design control integration
Greenlight Guru is a cloud-based electronic Quality Management System (eQMS) platform purpose-built for medical device companies to achieve and maintain ISO 13485 compliance. It provides interconnected modules for design controls, risk management (ISO 14971), CAPA, audits, complaints, training, and supplier management, ensuring full traceability and audit readiness. The software streamlines quality processes with medtech-specific templates, automation, and real-time reporting to reduce manual effort and regulatory risks.
Pros
- Purpose-built for ISO 13485 and medtech regulations with pre-configured workflows and templates
- Superior traceability and integration across all quality processes
- Robust analytics, dashboards, and audit-ready reporting
Cons
- Higher pricing may deter very small startups
- Initial configuration requires expertise for complex implementations
- Limited customization outside medtech-specific needs
Best For
Medical device companies ranging from startups to enterprises needing a comprehensive, compliant ISO 13485 QMS.
Pricing
Custom quote-based pricing, typically starting at $20,000-$50,000 annually depending on company size, users, and modules.
MasterControl
enterpriseComprehensive QMS platform for life sciences with robust document control, CAPA, and audit management supporting ISO 13485 requirements.
Pre-validated Connected Processes platform that automates workflows across document control, CAPA, and eDHR with built-in ISO 13485 compliance checks and real-time intelligence
MasterControl is a robust enterprise Quality Management System (QMS) software tailored for regulated industries, with strong support for ISO 13485 compliance in medical device manufacturing. It provides integrated modules for document control, CAPA, audit management, training, complaints handling, supplier quality, and electronic Device History Records (eDHR). The platform automates workflows, ensures traceability, and delivers pre-validated tools to meet FDA 21 CFR Part 11 and ISO standards, helping organizations maintain compliance while improving efficiency.
Pros
- Comprehensive ISO 13485-compliant modules with deep integration for end-to-end quality processes
- Strong automation, electronic signatures, and audit trails for regulatory adherence
- Scalable for global enterprises with robust reporting and analytics
Cons
- Steep learning curve and complex initial setup requiring significant training
- High implementation costs and time investment
- Pricing can be prohibitive for smaller organizations
Best For
Mid-to-large medical device manufacturers needing a scalable, fully validated QMS for ISO 13485 compliance and complex regulatory environments.
Pricing
Custom enterprise pricing; annual subscriptions typically start at $50,000+ based on modules, users, and deployment scale—contact for quote.
Qualio
specializedModern eQMS for life sciences startups and scale-ups, streamlining ISO 13485 processes like training, complaints, and quality events.
Unified Quality Events module that intelligently links incidents, CAPAs, changes, and audits into automated, traceable workflows
Qualio is a cloud-based electronic Quality Management System (eQMS) tailored for life sciences and medical device companies, enabling compliance with ISO 13485 through streamlined document control, training management, and quality event handling. It centralizes processes like CAPA, non-conformances, audits, and supplier management in a single platform, reducing manual work and ensuring traceability. The software supports scalability from startups to enterprises while maintaining audit-ready records and regulatory alignment.
Pros
- Comprehensive ISO 13485-compliant modules including document versioning, electronic signatures, and automated workflows
- Modern, intuitive interface with mobile app for on-the-go access
- Strong integrations with tools like Jira, Slack, and lab systems for seamless operations
Cons
- Pricing can be steep for very small teams or startups
- Advanced reporting and custom analytics require setup expertise
- Limited offline functionality due to cloud-only architecture
Best For
Mid-sized medical device companies needing a scalable eQMS for ISO 13485 compliance without heavy IT overhead.
Pricing
Custom enterprise pricing starting around $1,200/month for small teams (5-10 users), scaling with users, storage, and modules; annual contracts common.
ComplianceQuest
enterpriseSalesforce-powered QMS offering end-to-end ISO 13485 compliance with modules for document management, supplier quality, and audits.
Native Salesforce integration enabling real-time quality data synchronization with sales, service, and customer management workflows
ComplianceQuest is a cloud-based Enterprise Quality Management System (EQMS) built on the Salesforce platform, specifically designed to support ISO 13485 compliance for medical device manufacturers. It offers comprehensive modules for CAPA, audits, complaints handling, document control, risk management, supplier quality, and training management. The platform streamlines quality processes, ensures regulatory adherence, and integrates seamlessly with CRM functionalities for a holistic view of operations.
Pros
- Robust ISO 13485-specific features including design controls and risk management
- Deep Salesforce integration for unified quality and customer data
- Scalable for enterprise-level medical device companies with strong configurability
Cons
- Steep learning curve due to Salesforce foundation and extensive customization options
- Pricing can be high for smaller organizations
- Implementation may require dedicated IT resources or consultants
Best For
Mid-sized to large medical device manufacturers seeking an integrated QMS-CRM solution for ISO 13485 compliance.
Pricing
Quote-based enterprise pricing, typically starting at $100-150/user/month with annual contracts and additional fees for implementation.
ETQ Reliance
enterpriseFlexible enterprise QMS with AI-driven insights for ISO 13485, focusing on CAPA, complaints, and continuous improvement.
No-code configurable workflows that dynamically adapt to unique ISO 13485 quality processes without custom development
ETQ Reliance is a flexible enterprise quality management system (eQMS) designed for regulated industries, including medical devices, to ensure compliance with ISO 13485 through robust process automation. It provides modules for CAPA, audits, document control, complaints, supplier management, and risk-based workflows tailored to medical device quality requirements. The platform emphasizes configurability, allowing organizations to adapt it to specific ISO 13485 needs without extensive coding.
Pros
- Highly configurable workflows that adapt to ISO 13485 processes like design controls and risk management
- Strong audit trail and e-signatures for regulatory compliance
- Advanced analytics and reporting for quality metrics
Cons
- Steep learning curve due to extensive customization options
- Implementation requires significant time and expertise
- Premium pricing may not suit smaller medical device firms
Best For
Mid-to-large medical device manufacturers needing a scalable, highly customizable eQMS for complex ISO 13485 compliance.
Pricing
Subscription-based, typically starting at $50,000+ annually for mid-sized deployments, scaling with users and modules; custom quotes required.
SimplerQMS
specializedCloud QMS tailored for life sciences with strong document control and collaboration features for ISO 13485 certification.
Seamless Microsoft Office 365 integration allowing direct editing in Word/Excel with automatic version control and compliance checks
SimplerQMS is a cloud-based Quality Management System (QMS) software designed specifically for the life sciences industry, with strong support for ISO 13485 compliance in medical device manufacturing. It centralizes document control, CAPA, training management, complaints handling, and audits, featuring electronic signatures, full audit trails, and 21 CFR Part 11 validation. Built on the Microsoft platform, it offers seamless integration with Office 365 and SharePoint for efficient quality processes.
Pros
- Robust ISO 13485 and regulatory compliance tools with validated e-signatures
- Native Microsoft 365 integration for familiar document handling
- Configurable workflows and automation for CAPA and training
Cons
- Pricing can be high for smaller teams or basic needs
- Customization requires some technical setup
- Limited native mobile app functionality
Best For
Medium-sized medical device companies needing a scalable, Microsoft-integrated QMS for ISO 13485 compliance.
Pricing
Subscription-based; starts at approximately €400-600 per user/month, with custom quotes based on modules and users.
Dot Compliance
specializedNo-code eQMS platform enabling customizable workflows for ISO 13485 compliance in medical device quality management.
No-code workflow configurator that allows users to tailor ISO 13485 processes without IT involvement
Dot Compliance is a cloud-based Quality Management System (QMS) platform tailored for life sciences and medical device companies to meet ISO 13485 requirements. It provides end-to-end tools for document control, CAPA management, training tracking, audits, supplier management, and nonconformance handling with built-in electronic signatures and validation features. The software emphasizes configurable workflows and audit trails to ensure regulatory compliance and streamline quality processes.
Pros
- Comprehensive ISO 13485-aligned modules including CAPA, audits, and training management
- Configurable workflows and electronic signatures for quick customization
- Strong validation tools and 21 CFR Part 11 compliance support
Cons
- Pricing can be steep for small startups
- Steeper learning curve for advanced configurations
- Limited native integrations with some ERP systems
Best For
Mid-sized medical device manufacturers needing a scalable, configurable QMS for ISO 13485 certification and ongoing compliance.
Pricing
Quote-based subscription starting around $500/user/month for basic plans, scaling to enterprise tiers with custom features.
ValGenesis
specializedDigital validation and QMS solution for paperless ISO 13485 processes, including electronic signatures and audit trails.
Touchless, paperless validation with reusable test scripts and real-time execution analytics
ValGenesis is a cloud-based Digital Validation Platform (DVP) tailored for life sciences, including medical device manufacturers, to manage the full validation lifecycle in compliance with ISO 13485, 21 CFR Part 11, and other GxP regulations. It enables paperless validation processes, risk-based approaches, and real-time execution with electronic signatures and audit trails. The platform integrates with enterprise systems to streamline IQ/OQ/PQ testing and reporting, reducing validation timelines significantly.
Pros
- Comprehensive ISO 13485 compliance with built-in risk management and audit trails
- Paperless validation accelerates processes by up to 70% per user reports
- Scalable cloud deployment with strong data integrity features
Cons
- Steep learning curve for complex configurations
- High implementation and customization costs
- Limited out-of-box integrations with non-standard systems
Best For
Medical device companies needing a robust, fully validated platform for end-to-end lifecycle management under ISO 13485.
Pricing
Custom enterprise pricing; typically starts at $50,000+ annually for mid-sized deployments, plus implementation fees.
AssurX
enterpriseIntegrated QMS for quality events, regulatory compliance, and risk management aligned with ISO 13485 standards.
Canvas no-code configuration platform enabling quality teams to build and adapt workflows without IT involvement
AssurX is an enterprise quality management system (eQMS) tailored for regulated industries, including medical devices, providing robust support for ISO 13485 compliance through automated workflows for CAPA, complaints, audits, supplier management, and training. Its model-driven architecture allows for extensive customization without coding, ensuring scalability across global operations. The platform excels in risk-based quality processes and integrates seamlessly with ERP and other enterprise systems.
Pros
- Highly configurable no-code workflows via Canvas tool
- Comprehensive modules fully aligned with ISO 13485 requirements
- Strong integration and reporting capabilities for enterprise use
Cons
- Steep learning curve and lengthy implementation
- Premium pricing not ideal for small teams
- Overly complex for basic compliance needs
Best For
Mid-to-large medical device manufacturers requiring a scalable, highly customizable eQMS for ISO 13485 compliance in complex global operations.
Pricing
Custom enterprise pricing; typically starts at $50,000+ annually based on users, modules, and deployment (SaaS or on-premise).
Ideagen Quality Management
enterpriseSuite of quality tools for document control, audits, and CAPA to support ISO 13485 in regulated industries.
Integrated FMEA and risk register with automated linkages to CAPA and design controls for proactive ISO 13485 compliance.
Ideagen Quality Management, powered by solutions like Q-Pulse, is a robust enterprise-grade Quality Management System (QMS) designed specifically for ISO 13485 compliance in the medical device industry. It provides comprehensive tools for document control, CAPA management, internal audits, risk assessment (including FMEA), supplier management, and training records to ensure regulatory adherence and audit readiness. The platform emphasizes traceability, electronic signatures, and automated workflows to streamline quality processes across the product lifecycle.
Pros
- Highly configurable modules tailored for ISO 13485 requirements like risk management and CAPA
- Strong audit trail and reporting for regulatory inspections
- Scalable for growing medical device organizations with multi-site support
Cons
- Steep learning curve for initial setup and customization
- Pricing can be prohibitive for small teams
- Interface feels dated compared to modern SaaS competitors
Best For
Mid-sized to large medical device manufacturers needing a proven, compliant QMS for complex, multi-site operations.
Pricing
Quote-based enterprise pricing, typically starting at $10,000-$20,000 annually for basic deployments, scaling with users and modules.
Conclusion
The reviewed tools offer a spectrum of options to address the nuances of ISO 13485 compliance in medical device quality management. At the top, Greenlight Guru stands out as the leading choice, with specialized features tailored to design controls, risk management, and end-to-end compliance for medical device companies. MasterControl and Qualio follow closely as strong alternatives—MasterControl with its comprehensive QMS capabilities and Qualio for startups and scale-ups needing streamlined processes.
Take the next step toward efficient, stress-free compliance by exploring Greenlight Guru, a tool built to simplify your ISO 13485 journey and empower your team.
Tools Reviewed
All tools were independently evaluated for this comparison