20 Best QMS Software For Medical Devices

In this article, I will discuss the best QMS software for medical devices, highlighting their importance in ensuring compliance with regulatory standards and maintaining high-quality product development.

These systems streamline quality management processes, enhance collaboration, and provide real-time data insights, ultimately helping manufacturers mitigate risks and improve patient safety. Let’s explore the top options available in the market today.

Key Points & Best QMS Software For Medical Devices List

Software	Key Features
MasterControl	Document control, CAPA, audits, eQMS
Greenlight Guru	Medical device-specific QMS, Risk & Design control
Qualio	Document management, Training, CAPA
Arena PLM & QMS	Product lifecycle, Supplier collaboration
AmpleLogic Electronic	Automated workflows, Audits, Compliance tracking
ETQ Reliance QMS	Compliance management, Risk management, CAPA
TrackWise	Compliance tracking, CAPA, Workflow automation
Intellect	eQMS with dynamic forms, Document management
QT9 QMS	Training management, Audit tracking, Compliance
Teamcenter	PLM and QMS integration, Document control
Ideagen Quality Management	Risk management, Compliance, Reporting tools
Matrix Requirements	Requirement management, Traceability
Propel	QMS and PLM, Training & Supplier management
1factory	Quality inspection, Reporting, Real-time monitoring
Orcanos	ALM-QMS integration, CAPA, Risk management
Simploud	Validation management, Quality tracking
DELMIAWorks	ERP & QMS integration, Inventory management
ComplianceQuest	eQMS, Compliance, Supplier and Risk management
qmsWrapper	Document management, Workflow automation, CAPA
Cority Platform	EHSQ management, Audits, Compliance
Scilife	Quality, Supplier, and Risk management
QAD EQMS	Document management, Audits, Risk & Compliance

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20 Best QMS Software For Medical Devices

1.MasterControl

MasterControl is one of the best QMS software available for a medical device company that provides credible features such as document control, CAPA, audit trails and risk management. It is compliant with regulatory frameworks, strategies e.g.

FDA 21 CFR part 11 and ISO 13485 which reduces time for both device development and post-marketing procedures. The platform is available in cloud or on-premises deployment making it flexible and very useful as it allows for remote working.

With its emphasis on automation and traceability, it enables customers to efficiently deliver solutions to meet strict quality standards, which is suitable for medical devices as an example.

Features MasterControl

• Advanced document control comprising both a centralized office and a tracking system for multiple versions of the document with ease.
• Automatic workflows concerning CAPA (corrective action plan procedures) creating a systematic approach to Quality concerns.
• Comprehensive systems for managing an audit making within and external audits easy.
• Executive reporting and ad-hoc reports and analysis have immediately increased access to quality measures.
• A comprehensive approach to training that combines all management aspects and ensures monitoring of training compliance for all the employees.

2.Greenlight Guru

Greenlight Guru which is claimed to be the best QMS out there is also specifically designed for the medical device sector. There is resource for document control, risk management,

Design history, and CAPA, all pertinent to the medical industry standard and regulations like ISO 13485 and FDA applicable laws.

The best software is Web based and simple to use as the app allows one to see the whole process in real time and stimulates and ever optimizes the product lifecycle from initial design to post market.

Such capabilities allow the use of Greenlight Guru risk and quality modules and other tools helping medical device makers meet regulatory requirements and shorten time-to-market for their products.

Features Greenlight Guru

• A quality management system specifically meant for the medical device sector that addresses relevant regulations and standards.
• Embedded risk management tools that assist in the evaluation and elimination of possible product risks.
• Collaborative capabilities that improve communication and teamwork across departments of all levels within the organization.
• Easy to use system that reduces complexity in managing documents and control over their revisions.
• Automatic feedback within the system about compliance issues to facilitate an easier process of applying to regulations and examining the documentation.

3.Qualio

Qualio is a QMS designed specifically for the life sciences sector, such as manufacturers of medical devices. It streamlines the processes associated with document management, CAPA, and training and audits while adhering to ISO 13485, FDA 21 CFR Part 11, among other regulations.

As many small to mid-sized companies would appreciate, its simple interface promotes ease of use and teamwork, thus reducing onboarding time.

Qualio provides organizations with quality process management tools and ensures that traceability is embedded in the entire development process. The scalability of the platform, its user-friendliness has made it one of the preferred solutions by the active medical device market.

Features Qualio

• A cloud application where users can access quality management tools at any location.
• The documents submission process is automated, thereby minimizing the number of manual activities and mistakes.
• A useful tracking mechanism for every member of staff’s training and their qualifications.
• The system comes with managerial functions that are capable of reporting key quality parameters and trends.
• The solution also incorporates other business applications which assist in effective performance across all business functions.

4.Arena PLM & QMS

Arena PLM & QMS is a comprehensive cloud service, combining PLM with QMS – two vital organs for every medical device company.

It effectively guarantees collaboration throughout the different disciplines, stakeholders and regulatory requirements such as FDA and ISO 13485.

The platform comes with applications for document management, CAPA, risk assessment, and design history files (DHF), thus integrating quality management and product development processes into one system.

The all-in-one platform of Arena will get devices into the market faster, guarantee easier tracking and reduce the impact of regulatory inspections for medical device industries.

Features Arena PLM & QMS

• The presence of Product Lifecycle Management (PLM) and Quality Management System (QMS) to enhance business processes.
• Well implemented change management processes which ensure tracking and controlling of products changes.
• Tools for supplier collaboration, communication, and monitoring quality with the vendors.
• User portion features which provide evidence of being compliant with regulations and being able to track all the processes over the life of the product.
• Access to product quality information and data to enable improvement in activities through active processes.

5.AmpleLogic Electronic

AmpleLogic Electronic QMS offers tailored solutions to each medical device corporation in various ways. This includes the automation of quality processes including CAPA, audits, control of managed documents, and risk management to meetFDA and ISO 13485 requirements.

Additionally, it can be deployed either in the cloud or on-site so as to enhance flexibility and scalability. The no-code workflow engine from AmpleLogic enables the organizations to develop processes

With little reliance on IT making it best for achieving efficiency in compliance activities and in asset traceability across the entire product lifecycle.

Its automation features increase operational efficiencies which help medical device manufacturers reduce errors and speed up time to market.

Features AmpleLogic Electronic

• Effective control and retrieval of documents for an efficient and comprehensive electronic document management system.
• Configurable workflows that follow a certain quality management process and its requirements.
• Active Quality Assurance through the use of integrated CAPA management tools which enables effective closure of quality concerns.
• Monitoring and tracking of compliance and quality performance with respect to compliance and quality performance in real-time.
• Consideration of the interface of the system for ease in training the new users of the system escalating the time taken to onboard new users.

6.ETQ Reliance QMS

ETQ Reliance is an advanced, sophisticated and cloud-based QMS which accounts for the specialized requirements of multi-faceted medical device industries and offers advanced features for document management, CAPA, audits, risk and supplier quality management in full compliance with FDA 21 CFR Part 11 and ISO 13485.

The strength of the platform can be customized through the use of its modular structure enabling organizations to delineate workflows in accordance with existing operational procedures.

ETQ’s embedded analytics tools overcome time lag as they integrate with current reporting tools for better decision making and increased operational effectiveness.

With its emphasis on automation and scale, ETQ Reliance assists medical device manufacturers in meeting regulatory standards, enhancing product quality, and managing risks throughout the product life cycle.

Features ETQ Reliance QMS

• A modular architectural design that can be tailored to fit the requirements of an organization’s ever evolving goals.
• Techniques that will assist in risk prevention, assessment, and reduction of possible quality threats on products or services.
• A functionality that provides processes for the preparation, execution and monitoring of the results of the audit.
• Interactive dashboards and analytics that offer insights into quality measures present and developing in the organization.
• The ability to connect with various kinds of enterprise systems focused on enhancing [organizational] quality and operations.

7.TrackWise

TrackWise by Sparta Systems has built a respectable portfolio as a QMS solution for medical devices, providing comprehensive capabilities for CAPA, audits and inspections, complaint and change management.

It complies with the requirements of FDA 21 CFR Part 11, ISO 13485 and other worldwide provisions. The flexibility of TrackWise is well recognized as it allows custom designed workflows and is compatible with other enterprise systems.

TrackWise provides a great set of tools for reporting and analytics, enabling users to develop insights for enhancement. This tool is offered in cloud and on-premise configurations

And it supports medical device makers in terms of improved quality, regulatory compliance and process consolidation during product lifecycle.

Features TrackWise

• Efficient and effective capture of quality issues through a structured and focused improvement process.
• End-to-end tracking of audit planning, fieldwork and reporting phases of an audit.
• Management of compliance and version control.
• Ability to access trends and statistics regarding quality through customizable reports.
• Cross-compatibility with ERP and other systems for effective data sharing.

8.Intellect

Intellect provides medical device companies with a configurable QMS platform that has no-code elements which is quite unique.

It facilitates several quality processes such as CAPA, document control, management of training, and audits which meets compliance to standards like FDA 21 CFR Part 11 and ISO 13485.

Its easy-to-use workflow builder makes it possible for companies to develop processes without having to be programmers. Intellect allows control of quality throughout the organization

Because of cloud deployment, real time interaction, and mobile access. Such convenience and features can be valuable to medical device manufacturers that are striving towards better compliance and efficiency as well as improved product quality.

Features Intellect

• No-code Integration feature enable user to create workflows and to incorporate desired changes without programming.
• Management of quality system processes such as documents control, CAPA or nonconformance.
• Mobile solutions – to manage quality processes and documents while outside the premises.
• Compliance management with respect to national and international regulations and standards.
• Fully functional learning management system to track employees’ qualifications or efficiency of training sessions.

9.QT9 QMS

QT9 QMS is an all-in-one, configurable and scalable quality management software which is cloud based specifically for the medical device industry.

It includes some key functions like document control, CAPA, audit management and training management that are essential for meeting ISO 13485 and FDA norms.

The system is easy to use and compatible with all other organizational systems. With the ability to integrate with how businesses operate

QT9 QMS’s automation features enhance workflow and reduction of manual errors. Considering its low cost and high scalability

QT9 QMS is best suited for small sized to medium sized medical device manufacturers who are targeting improvement of quality management and compliance to regulations.

Features QT9 QMS

• A centralized interface that is accessible from anywhere allowing tools of quality control to be utilized.
• Version control as well as endorsement processes are made easy through document management systems.
• All relevant information regarding how customers’ expectations have been met is collated to improve customer requirements and satisfaction.
• Management of CAPA – this is aimed at following up and addressing all pertinent quality issues.
• Mature reporting tools that coverage how compliance and different quality performance indicators are met.

10.Teamcenter

We are pleased to introduce Teamcenter which is a full-featured product lifecycle management (PLM) and quality management system (QMS) for the medical device industry.

It combines quality processes with product data management, including document control, CAPA, compliance, and risk management tools.

Teamcenter guarantees FDA requirements and ISO 13485 is complied with, ensuring legal requirements during the entire product lifecycle.

Its cloud-based and scalable platform enhances teamwork with global teams and suppliers, strengthens productivity and increases visibility.

Teamcenter provides medical device producers with advanced analytics and reporting functionalities to ensure quality, enhance operational efficiency, and improve time-to-market.

Features Teamcenter

• Marrying PLM and QMS functions for effective product and quality data management.
• Sophisticated change initiatives management that handles design changes and documentation.
• Advanced features which assists in working and communicating across functions.
• Sound compliance management capabilities in relation to regulatory requirements.
• Comprehensive reporting and analytics measures to improve understanding of product quality and lifecycle impact.

11.Ideagen Quality Management

Focus on medical devices, Ideagen Quality Management is a rich-featured, cloud based QMS software which is ISO 13485 and FDA compliant with features like document control, CAPA, risk management, and audit management.

The platform also has a well designed interface that promotes easy access and collaboration among teams involved in quality processes, improving overall quality work.

Moreover, Ideagen also provides effective analytics and reporting tools to assist in ongoing improvements and better decision making through the information provided.

By possessing a strong emphasis on complying and assuring quality, Ideagen Quality Management enables its clients to refine their operations and reduce their exposures while being consistent throughout the product life cycle.

Features Ideagen Quality Management

• An integrated document control procedure that permits the management, tracing, and custody of documents pertinent to the quality system.
• Tools for management of corrective action and preventive action that allow the methodical approach to prevention and other resolution of quality deficiencies.
• Integrated features for risk management to assist in the early identification and control of potential risks.
• Navigation is enhanced with easy to follow interface designed to improve the user experience.
• Desktop, easy to create and edit, dashboards as well as reports which provide actual insight into the quality of processes.

12.Matrix Requirements

Matrix Requirements is a dedicated QMS application, implemented within the medical device sector, which centers around requirements management and regulatory compliance.

It encompasses the functions of document control and risk, audit, and traceability management compliant with various ISO 13485 and FDA requirements.

The platform includes intuitive functionalities that promote interaction and collaboration among projects teams through instant communication and efficient project update.

Besides, it has a sound report and analytic capacity that allows the Matrix Requirements to help firms control and monitor their quality processes.

Such versatility and emphasis on regulatory compliance are beneficial to medical device producers wishing to create a better quality management system or enhance product design.

Features Matrix Requirements

• It has advanced requirements management which includes proper traceability for any product at any stage of a product’s life cycle.
• Tools for risk assessment are integrated to assist with project risk evaluation and management.
• It provides document control so that versions are compliant to any regulatory obligations.
• It has a simple and easy to use interface allowing teams to work together across different areas.
• Rich reporting capabilities that allow the status of the requirements and the level of completion of the project to be known.

13.Propel

The Propel cloud-based QMS and PLM Software is focused on the medical device industry. It serves as link between quality management and product development through document control, CAPA as well as risk management tools.

Propel aids in FDA and ISO 13485 compliance with improved collaboration among teams and suppliers. The interface is intuitive and supported with strong analytics to allow users continuous

Improvement making it a great solution for medical device manufacturers looking to simplify quality activities and speed up the market entry of their products.

Features Propel

• Integrated PLM and QMS aimed at product development and quality management.
• Web-based software that supports online work between engaged members of different departments.
• Built-in submission tools to facilitate compliance with relevant requirements and alleviate the need for manual checks
• Additional functionality of advanced revision control to track changes of the products effectively.
• Built-in tools for the design of workflows customized for certain procedures and quality management.

14.1factory

1factory is a QMS that operates in the cloud particularly for the medical devices industry which concentrates on inspections and compliance.

The features contained include document control, CAPA, and audit management in effort to comply with the demands of the FDA and ISO 13485.

The platform improves collaboration and end-to-end processes by providing visibility of quality’s various functions within teams.

Because of its straightforward design and automation functionalities, 1factory assists medical device manufacturers in achieving higher efficiency and lower error rates while delivering outstanding quality within the entire life cycle of the product.

Features 1factory

• All-round quality evaluation management system that enables to monitor and report inspection processes.
• Effective automated data collection instruments which make the input and examination of quality particulars easy.
• Availability of quality indicators on the spot to enable swift action.
• Simple and intuitive interface which assists users to conveniently utilise the available quality tools.
• Functionality to connect to current systems in order to improve the processes and reduce inaccuracies in the data.

15.Orcanos

Orcanos is a one-stop QMS and ALM that caters exclusively to the medical device sector. Processes like document control, CAPA, and risk management are featured and are FDA and ISO 13485 compliant. In addition, with Orcanos, users are provided with a clear interface and configurable workflows further increasing coordination and effectiveness between teams.

Thanks to its strong traceability and audit features, compliance with regulatory requirements is made easy and allows for a smooth submission of Orcanos as an ideal solution for medical device manufacturers looking to improve quality management and speed up development time of the product.

Features Orcanos

• An all in one QMS and ALM system specifically designed for the medical device industry.
• Advanced requirements management methodologies for tracking and compliance needs.
• Matrix based capabilities for evaluating and decreasing product risk effectively.
• Management of audits including planning, performing and reporting of audits made easy.
• User-modifiable templates that show the current level of quality and the stage of the project.

16.Simploud

Simploud stands out as a QMS hosted in the cloud specifically designed for medical device companies, aiming at validation and compliance management. Its main components include management of documents, CAPA, and conducting internal audits that comply with the FDA and ISO 13485 requirements.

Being user friendly, Simploud improves quality processes and improves spatial collaboration between teams. The pre-built validation processes of the platform not only improve efficiency but also minimize compliance risks so Simploud is well suited for medical devices manufacturers who desire to sustain high standard quality and adhere to regulatory requirements in every stage of the product lifecycle.

Features Simploud

• Quality assurance has never been easier with an online quality management system which promotes accessibility and teamwork.
• There are automated processes to validate that the organization adheres to compliance requirements.
• eQMS has incorporated all organizational policies, procedures, and records management, into a uniform document control system.
• Wide range of administrative activities to manage employees qualification, participation in training and their progress.
• Simple reporting capabilities for viewing quality and all compliance reporting, call monitoring results.

17.DELMIAWorks

DELMIAWorks is also a comprehensive ERP and QMS application which meets the unique requirements of the medical device industry. Its quality management features such as CAPA, document control, and compliance tracking integrate to guarantee conformity to standards such as the FDA and ISO 13485.

It provides the ability to monitor operations and conduct analysis in a bid to improve performance. Owing to its emphasis on integration of manufacturing processes

DELMIAWorks improves quality processes and enables teamwork across members which makes it suitable for medical device manufacturers who want to enhance quality and compliance with regulations.

Features DELMIAWorks

• A flexible combination of ERP and QMS integration improving manufacturing and quality processes across the board.
• Upitive production supervision to enhance operations and quality.
• Sophisticated analytics and reporting tools for decisions based on facts and further development of the company.
• Varied quality management modules which can be redesigned to tackle particular business requirements.
• Supplier Quality management functionalities for vendor assessment and performance review.

18.ComplianceQuest

ComplianceQuest is a specialized QMS SaaS solution for the medical device market providing complete functionalities for document control, CAPAs, audit and risk management. Ensures compliance with FDA regulations and ISO 13485.

It features an easy to navigate interface together with automation to foster teamwork and enhance quality activities across the organization. With comprehensive reporting and analytics capabilities

ComplianceQuest enables manufacturing companies of medical devices to boost their operational effectiveness, acquire quality control, and ease the regulatory burden throughout the product lifecycle.

Features ComplianceQuest

• Lets you manage quality related processes in the cloud, enabling you to access them easily from anywhere.
• Complete and systematic management of quality issues to prevent their recurrence in order to deliver consistent quality.
• A comprehensive management and monitoring of employee training and compliance processes.
• Sophisticated and well developed systems for preparing, executing and running audits without difficulty.
• Excellent reporting and analytical tools for monitoring critical quality indicators and compliance requirements.

19.qmsWrapper

qmsWrapper is a bespoke secure cloud-based QMS specifically developed for the medical device sector with an emphasis on quality management and quality regulatory obligations.

It provides basic components including controls over documents, CAPA, audits, and training records management which are in compliance with the FDA and ISO 13485 requirements.

qmsWrapper’s easy-to-use interface makes it easier for users to perform quality operations and work together. The platform’s automation aspects eliminate the chances of making manual errors and improve the ease of performing tasks

Hence qmsWrapper being the best option for medical device producers who need to enhance quality management processes and satisfy legal requirements.

Features qmsWrapper

• Intuitive interface easy to use within the medical device industry environment.
• Robust document control functions and electronic versions management to enhance document management.
• Integrated processes for generation of CAPA, management of nonconformance and complaints handled electronically.
• Facilities for risk assessment and evaluation embedded in both the process and tool to manage quality risk.
• Attributes that enable rapid tracking of performance indicators on dashboards and compliance status are user-specified.

20.Cority Platform

The comprehensively expressed platform has been designed keeping the medical devices perspective and is based on the Cloud. The platform ensures document control, CAPA, risk management and general compliance along with the procedures.

FDA and ISO 13485 compliant systems are made which allows for integration of quality and compliance processes effectively. Advanced analytics design improves organizational and decision-making efficiency providing real time operational insights.

The platform appreciates and has regard for compliance as well as improvements so it can be used by the medical device manufacturers in the optimization of their QMS systems.

Features Cority Platform

• With this application the user gets access to the fully integrated quality, health, safety and environmental management system.
• With the full suite of Advanced risk assessment tools businesses are able to assess, manage and control potential threats.
• The ability to manage quality matters from any place and at any time.
• Through the Flexible Reporting Perspective users are able to access information that addresses the concerns of their organization.
• Offers users seamless integration with any enterprise systems they have, enhancing data interoperability and productivity.

Reasons To Choose Best QMS Software For Medical Devices

Compliance: Helps satisfy strict regulations such as FDA 21 CFR Part 11 and ISO 13485 and minimizes the chances of incurring non-compliance penalties.

Process Automation: Automating quality management tasks such as document control, CAPA, and audits reduces efficiency and the need for manual processes.

Improved Communication: Guarantees that all teams, vendors, and key players are on the same page when it comes to quality goals and boosts communication and cooperation.

Data and Analytics: Presents pertinent information on a variety of dimensions of quality and helps in making timely and relevant decisions while addressing issues that arise in the future.

Flexibility: Provides solutions that can be varied to fit the future growth and increased complexity and regulations in line with organizational expansion.

Document Management and Control: Ensures that there is full control of documents and processes that is critical during the time of audits or regulatory inspections.

Conclusion

It is very important to choose the best QMS software for medical devices as it best helps with compliance, improved efficiency, and product quality.

These enable features such as regulatory compliance, business process automation and analytics dashboards to make these systems effective in enhancing quality management and collaboration.

Medical device manufacturers are able to improve operational performance and therefore reduce risks and in the end improve patient safety and satisfaction through the investment in a potent QMS.