Top 6 Quality Management System Software for Medical Devices

Maintaining quality and adhering to strict regulatory requirements is critical in the medical devices industry. Traditional quality management systems often fall short as they typically combine general-purpose tools and paper-based processes held together by a loosely organized team. 

This approach lacks accountability and traceability, rendering such QMS ineffective for the medical devices sector. Therefore, there is a critical need for a robust quality management system (QMS) customized for the medical devices industry. The chosen QMS should manage all quality processes within a closed-loop system, ensuring comprehensive oversight, regulatory compliance, and continuous improvement.

With this in mind, we’ve written this guide to help you through the top 6 quality management systems available to medical device manufacturers. Our goal is to assist you in making an informed decision that best fits your business needs.

‍

Top 6 QMS Software for Medical Device Companies 

‍

1. Greenlight Guru

Medical device companies face complex quality management challenges and strict regulatory requirements. An electronic quality management system (eQMS) like Greenlight Guru can help ensure compliance, improve efficiency, facilitate collaboration, and scale quality management processes. Greenlight Guru is a cloud-based eQMS built exclusively for the medical device industry. Its vision is to improve the quality of life by helping medtech companies bring the highest-quality products to market faster and maintain their market presence.

Greenlight Guru has spent the past 16 quarters topping G2’s rankings as the leading QMS software, earning additional recognition for driving the best results for their customers.

‍

Key Features of Greenlight Guru for Medical Device Companies

1. Audit-tested Pre-built Document Templates

A library of pre-built document templates designed to help medical device companies streamline the documentation process, ensuring compliance with regulatory requirements such as FDA and ISO standards. Companies can thus save significant time and resources, reducing the risk of non-compliance and expediting the documentation process.​ 

2. Flexible Event Workflows with Form and Document Steps

Highly adaptable workflows that cater to various events within a medical device company's operations. These workflows include customizable form and document steps, allowing users to tailor the processes to their needs. All necessary documentation is captured accurately, facilitating smoother project management and regulatory compliance.​

3. Risk Management

The platform can identify, assess, and mitigate potential risks throughout the product lifecycle. It includes tools for risk analysis, hazard identification, and risk control measures aligned with ISO 14971 standards. Companies can proactively address potential issues, enhancing product safety and reliability.

4. AI Automation

By incorporating AI, the platform automates routine tasks such as document approval workflows, change management, and compliance tracking. It helps reduce manual efforts, minimize human error, and increase overall efficiency, allowing teams to focus on more strategic activities.

5. Expert Industry Quality/Regulatory Support

Provides extensive regulatory support through its team of quality and regulatory experts. Users can access resources like webinars, whitepapers, and personalized consultations to navigate FDA and ISO standards effectively. This support includes training programs to ensure teams stay updated with the latest industry best practices, enhancing compliance and product quality​.

To know more, visit: https://www.greenlight.guru/

‍

2. Qualio

Many medical device companies rely on multiple systems for quality management, resulting in a fragmented and inefficient approach. Some use a home-grown CAPA system or separate tools for design controls, while others are bogged down by paper-based processes that complicate quality management.

Qualio addresses these challenges by replacing legacy systems with a centralized, cloud-based eQMS accessible from anywhere. Its flexible workflows and templates enable companies to mature their quality processes as they scale. 

‍

Key Features of Qualio for Medical Device Companies

1. Document Management

It eliminates paper-based processes and provides a centralized digital repository for all documentation. Features like automated snapshots and e-signatures enhance compliance and traceability, making it easier for medical device companies to stay organized and compliant with regulatory requirements.

2.Training Management

Allows proper assigning and tracking training based on roles and responsibilities, ensuring that employees are adequately trained and updated on the latest procedures and regulations. 

3. Quality Event Management

It has robust tools for handling nonconformances, CAPAs (Corrective and Preventive Actions), and other quality events, with automated workflows that help streamline the entire process from identification to resolution​.

4. AI Automation for Risk Management

Leverages AI automation to enhance risk management practices. This feature allows for proactive risk detection and mitigation, identifying and addressing potential issues before they escalate, and maintaining higher safety and compliance standards.

5. Comprehensive Integration Suite

Integration is seamless with various business-critical applications, enabling medical device companies to automate workflows and centralize data. Teams can collaborate effectively and maintain a single source for all quality-related information for regulatory compliance and operational efficiency.

To know more, visit: https://www.qualio.com/

‍

3. Veeva Vault 

Veeva Vault QMS software offers a unified global quality management system, providing end-to-end process control and visibility for Medtech quality teams. It supports proactive management initiatives and enables seamless handling of non-conformances, CAPAs, audits, complaints, supplier management, and change control processes. Additionally, the system can be configured to meet specific organizational needs.

Key Features of Veeva Vault for Medical Device Companies

1. Document Management

Medical device companies can securely store, manage, and share documents throughout the product lifecycle. The platform ensures that all documents comply with regulatory requirements and can be easily accessed by authorized personnel. This capability helps maintain consistency, improve collaboration, and ensure compliance across the organization​.

2. Quality Event Management

Companies can efficiently track and manage quality events such as nonconformances, CAPAs (Corrective and Preventive Actions), and audits. The system automates workflows, ensuring that all quality events are addressed promptly and effectively, which helps maintain high-quality standards and regulatory compliance​.

3. Training Management

Veeva Vault helps organizations ensure that all employees are adequately trained and their training records are up-to-date. This module allows for creating, assigning, and tracking training programs, ensuring compliance, and improving workforce competence​.

4. Regulatory Information Management (RIM)

The Regulatory Information Management (RIM) suite helps streamline global regulatory processes, improve data quality, and ensure compliance with evolving regulations. Integrating various regulatory activities enhances visibility and agility in managing regulatory submissions and communications​.

5. eTMF and CTMS Functionality for Clinical Trials

Veeva Vault has tools to help maintain complete and compliant trial documentation, improving oversight and efficiency in clinical trial operations. The eTMF ensures that all trial documents are audit-ready, while CTMS provides robust trial management capabilities from planning to execution​.

To know more, visit: https://www.veeva.com/products/vault-qms/

‍

4. Dot Compliance

Dot Compliance offers the industry's first off-the-shelf Quality Management System (QMS) solution, designed for immediate deployment with minimal setup. The platform incorporates industry best practices and meets the latest regulatory standards, ensuring seamless compliance. Built on the robust Salesforce.com platform, Dot Compliance leverages technological innovation to simplify electronic QMS (eQMS) management and implementation. Eliminating complexities traditionally associated with quality and compliance systems empowers organizations to focus on quality control and regulatory adherence without the burden of lengthy setup processes.

‍

Key Features of Dot Compliance for Medical Device Companies

1. Ready-to-Deploy eQMS

Dot Compliance provides a fully operational, off-the-shelf electronic Quality Management System (eQMS) that requires minimal setup. It incorporates industry best practices and complies with the latest regulatory requirements, offering medical device companies immediate access to a comprehensive quality management solution from day one.

2. Document Control and Management

The platform enables streamlined document control by automating the management and tracking of critical documents such as Device Master Records (DMRs), Design History Files (DHFs), and SOPs. It ensures medical device companies meet FDA and ISO standards while maintaining up-to-date, secure documentation.

3. Compliance with Regulatory Requirements

Dot Compliance is designed to meet the latest regulatory standards, including FDA 21 CFR Part 11, ISO 13485, and other global regulations. This ensures medical device companies can manage their quality and compliance processes in a consistent and standardized way, minimizing risks of non-compliance.

4. Change Control and CAPA Management

The system offers integrated tools for managing change control and corrective and preventive actions (CAPAs). By providing full visibility into quality events and tracking their resolution, Dot Compliance helps medical device companies continuously improve quality processes and remain audit-ready.

5. Cloud-Based Flexibility

Powered by Salesforce, Dot Compliance’s cloud-based infrastructure ensures scalability, flexibility, and secure access from anywhere. This enables medical device companies to manage quality and compliance processes more efficiently across teams and locations.

6. Supplier Quality Management

The platform includes tools for managing supplier quality, allowing medical device companies to track supplier performance, ensure compliance with supplier standards, and mitigate risks associated with the supply chain.

To know more, visit: https://www.dotcompliance.com/medical-devices/

‍

5. Arena QMS

Arena's product-centric quality management system (QMS) integrates quality and product design into a single, secure platform. As a top choice for medical device manufacturers, Arena's QMS connects quality records directly to product design. It documents and tracks closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and corrective and preventive actions (CAPAs), all in context with the entire product record and bill of materials (BOM).

‍

Key Features of Arena QMS for Medical Device Companies

1. Document Management

Arena QMS connects quality and product designs into a single, secure system. This helps medical device manufacturers manage critical documents, such as device master records (DMRs), design history files (DHFs), standard operating procedures (SOPs), and training records. This integration simplifies compliance with FDA and ISO regulations, reduces audit risks, and ensures that all documents are up-to-date and easily accessible.

2. Training Management

Arena QMS system facilitates the maintenance of training records, automates the assignment of training tasks, and tracks completion. Ensuring that all personnel are adequately trained, Arena QMS helps medical device companies comply with regulatory requirements and maintain high-quality standards​.

3. Quality Event Management

Arena QMS provides robust tools for managing quality events, including non-conformances (NC), corrective actions (CA), and preventive actions (PA). This feature streamlines the documentation, tracking, resolution of quality issues, continuous improvement, and regulatory compliance. 

4. Detailed Quality Analytics

Arena QMS offers powerful analytics capabilities that help medical device companies identify trends, monitor key performance indicators (KPIs), and make data-driven decisions to improve quality and efficiency. 

5. Dedicated Product Lifecycle Management (PLM) Platform

Arena's PLM platform integrates seamlessly with its QMS to centralize all product and quality data, enhancing team visibility and collaboration. The platform supports design controls, production controls, and other regulatory requirements, helping medical device companies efficiently bring safe, compliant products to market.

To know more, visit: https://www.arenasolutions.com/platform/qms/

‍

6. MasterControl

The MasterControl QMS for medical device quality is an integrated suite of configurable solutions designed to facilitate sustained compliance effortlessly. By connecting disparate processes such as BOM management, supplier relations, CAPA, customer complaints, change control, and document management, MasterControl streamlines quality management operations. It helps companies comply with FDA 21 CFR Part 820 and other regulations, including ISO 13485. 

‍

Key Features of MasterControl for Medical Device Companies

1. Document Management

Automates the control and tracking of documents to ensure compliance with FDA's QSR 21 CFR Part 820 and ISO 13485 standards. It provides robust capabilities for electronic document routing, approval, signature management, and maintaining a comprehensive audit trail, which helps medical device companies reduce the risk of non-compliance and improve operational efficiency.

2. CAPA (Corrective and Preventive Actions) Management

Helps companies maintain compliance by ensuring that all CAPA-related processes are fully documented and tracked. This system integrates seamlessly with other quality processes, such as change control and nonconformance management, to provide a comprehensive solution for managing corrective and preventive actions​.

3. Training Management

The system supports compliance with regulatory requirements by maintaining accurate training records and providing real-time visibility into employee training status. It automates the assignment and tracking of training tasks to ensure all employees are adequately trained on the latest procedures and regulations. 

4. Nonconformance Management

The system provides tools for capturing detailed information about nonconformance incidents, investigating their root causes, and implementing corrective actions. By integrating with the CAPA system, MasterControl ensures that nonconformance issues are effectively managed and resolved.

5. Change Control Management

Enables medical device companies with a centralized platform to manage changes to products, processes, and documents in a controlled manner. It ensures that all changes are properly reviewed, approved, and documented to maintain compliance with regulatory requirements.

To know more, visit: https://www.mastercontrol.com/

‍

Conclusion

Staying ahead of the developments in the medical device industry is indispensable for success and compliance. We hope this curated list of quality management system software provides a comprehensive overview of tools tailored to the sector's unique needs, ensuring regulatory compliance, efficiency, and continuous improvement.