What’s the best eQMS software for medical device developers in 2025?

There are many eQMS platforms out there that have been helping medical device developers bring their products to market for decades. But which software offers the best value and support for an innovative and growing business?

First, let’s start with some key questions:

Why do companies need eQMS software? 

• Migrate from slow and error-prone paper-based systems
• Migrate from a patch-work of digital systems (like Google Docs and PandaDocs)
• Create a single source of quality truth in their organisation
• Accelerate and derisk their development process
• Improve compliance and auditing capabilities

How do they manage this process?

eQMS platforms differ in price tag, levels of customer support and the way they package up and interconnect their tools to help clients meet their quality and compliance goals.

But at the heart of every offering should be the tools you need for:

• Document control
• Deviation/Non-conformities management
• Design control
• CAPA (Corrective and Preventive Actions)
• E-signature integration (FDA CFR 21 Part 11/EU Annex 11 compliant)
• Risk management
• Change management
• Training management
• Audit management
• Supplier quality management

But the way you access and build out these quality functions within each eQMS can be very different.

What’s the time and effort required to get started? 

Some platforms will tie you to their way of working almost completely, using pre-set quality structures to help you meet ISO standards and FDA regulations. However, many customers find these incredibly restrictive, as they have to change their processes entirely to fit in with the software.

Some platforms even require you to shift your documentation into their native eQMS format in order to work with them, rather than simply migrate existing Word and Excel documents into their document structures. That’s a lot of effort and will make it hard to extract yourself from their system if you need to leave.

Starting with some of these heavy-duty eQMS may take several months and require extensive internal re-training, which can really affect the pace of your development.

How does the pricing work? 

Most eQMS platforms will offer different tiers of access depending on your company’s level of maturity. These might include start-up, scaling and enterprise packages with different levels of functionality and cost involved.

Depending on which company you work you may find yourself having to pay unexpected extra costs as you grow. You may have to buy more seats or pay for vital modules that weren’t included in your original package.  

The level of support you will receive to configure and shape your system will also vary depending on the size of your organisation and much you are prepared to pay.

Are these the top 6 eQMS platform choices for scaling medical device developers?

So, let’s look at 5 major eQMS platforms that medical device developers use around the world, to see if they will fit with your requirements.

And as an extra measure, let’s compare all those with ‘Doing it Yourself’ using SharePoint.

1. MasterControl

Established in 1993 and headquartered in Salt Lake City, Utah, MasterControl has grown into a globally recognised leader in eQMS solutions for the life sciences industry. With over 1,000 clients worldwide, including some of the largest names in pharmaceuticals, biotechnology, and medical devices, MasterControl provides powerful tools for managing compliance, document control, audits, and training. Known for its robust feature set, it is designed to meet the demands of highly regulated industries but can be overly complex for smaller, more agile businesses.

Pros:

• Comprehensive features: Provides robust SOPs, batch approvals, and a powerful Learning Management System (LMS) tailored for large pharmaceutical and biotech firms.
• Global collaboration: Excellent for distributed teams needing tight compliance with global regulations.
• Role-based workflows: Enhances continuity by linking processes to roles, not individuals.
• Connected system: All of MasterControl's modules are connected. Document management, training management, and Quality Event Management all talk to each another in order to streamline your processes.

Cons:

• Complex implementation: Lengthy onboarding (often several months) and difficult to adapt for SMEs.
• Rigid templates: SOP templates limit customisation for lean or agile teams.
• Costly: High upfront costs ($40K +/year) plus additional consultancy fees.
• Limited trials: Short trial periods restrict thorough evaluation before commitment.
• Lack of flexibility: An ‘all or nothing’ approach to adopting their quality management system can be daunting

2. Qualio

Founded in 2015 in Dublin, Ireland, Qualio was created to address the quality management needs of life sciences companies, particularly those navigating complex regulatory environments. With its headquarters now located in San Francisco, California, Qualio has grown to serve organisations globally, offering an accessible, cloud-based platform designed to help businesses streamline their quality processes. Qualio's stated mission is to break down the silos of development, manufacturing, and quality, helping life-science companies collaborate more effectively.

Pros:

• Long-standing reputation: Known for serving many high-profile clients in the life sciences industry.
• Integrated design: Connects risk management, quality events, and design control for real-time compliance tracking.
• Ease of collaboration: Strong integrations reduce silos and streamline workflows.
• Well-designed interface: Qualio has a clean and easy-to-use interface.

Cons:

• Costs: Packages start at $20K/year, but ramp up rapidly with onboarding fees, charges for additional features and long tie in periods.
• Closed document Ecosystem: Requires documents to be recreated in Qualio’s format, making migration slow and error-prone.
• Search function Limitations: Lacks intuitive browsing; relies heavily on tagging.
• Rigid Templates: Limited configurability may force companies to adjust existing workflows.

3. Greenlight Guru

Founded in 2013 and headquartered in Indianapolis, Indiana, Greenlight Guru is a purpose-built quality management software platform exclusively designed for medical device companies. By focusing on the unique needs of this industry, Greenlight Guru has developed an end-to-end solution that supports every stage of the product lifecycle, from design and development to post-market surveillance, ensuring compliance with stringent standards and regulations, including ISO 13485 and FDA 21 CFR Part 820.

Pros:

• Reputation: Widely known and recognised for medical device expertise, and a frequent choice for scaling businesses.
• Medical device focus: Tailored for FDA and ISO 13485 compliance with integrated design and risk management tools.
• Traceability: Strong in linking user needs, risk, and design requirements, providing traceable systems for compliance.
• Easy to get going: Greenlight gives you the tools and platform to follow a pre-determined process that allows you to get up and running quickly

Cons:

• Rigid workflows: Limited customisation options; compliance workflows can feel prescriptive and hard to reconfigure if they don’t fit your business.
• Expensive: Starting costs are still high ($30K+/year for viable packages), with mandatory 3-year contracts.
• One size fits all processes: The advantage of having templated SOPs can be a disadvantage for some companies. Without the flexibility to change them, they can over-complicate your compliance process – adding extra cost and bureaucracy that slows the pace of development down.

4. Q-Pulse

Developed by Ideagen, Q-Pulse is a robust quality management software solution designed to serve highly regulated industries, including aviation, life sciences, healthcare, manufacturing, and utilities. First introduced in the 1990s and headquartered in Nottingham, UK, Q-Pulse has become a trusted tool for organisations seeking to manage compliance, risk, and operational quality efficiently. Its modular approach allows different kinds of businesses to tailor the platform to their unique needs, offering a comprehensive suite of tools for document control, audit management, corrective actions, and more.

Pros:

• Versatile application: Supports various industries and regulatory standards.
• Comprehensive features: Covers document control, CAPA, audits, and risk management.
• Customisable: Modular design lets users tailor the system to their needs.
• Strong product management features: Manage real time product information and track BOMs throughout the entire product creation process

Cons:

• Steep learning curve: Can be complex for new users or smaller organisations.
• Outdated interface: Less intuitive compared to newer platforms.
• Product variations: Have acquired many different eQMS solutions and not everyone gets the same functionality.
• Rising costs: Packages start at $20K pa, not including onboarding.  These costs can rise to $30K/year as you add seats and essential quality modules.

5. Cognidox 

Founded in 2008 and headquartered in Cambridge, UK, Cognidox is an eQMS platform with a lean approach to design controls and quality, tailored for technology and innovation-driven industries.

It is designed to simplify med-tech compliance, enhance collaboration, and accelerate product development by centralising document control and quality processes. Cognidox was originally developed to support high-tech companies but has been widely adopted in the med-tech sector.

Pros:

• Ease of access: Lower cost solution particularly suited to SME's and companies transitioning from paper-based systems. Costs start from $9K/year for 20 users.
• Flexible: Simple interface with tools that facilitate collaboration, centralised document management and compliant e-signatures.
• Comprehensive quality modules: Full suite of modules included as standard covering everything from CAPAs and Training to Supplier Management.
• Document holders: Controlled documents that hold other controlled documents for statutory submissions, technical files, eTMF’s and design phase gate approvals.

Cons:

• Limited out-of-the-box integration: APIs are provided but only Microsoft Office and DocuSign integrations are available out of the box
• No automated traceability matrices: Matrices for risk management and design control must be built within underlying documents and linked together either using hyperlinks or meta-data.
• Document focus: Some users may not appreciate its document-centric approach to quality management

6. SharePoint

Developed by Microsoft, SharePoint is a popular document management and collaboration tool. While not a dedicated eQMS, it is often adopted by organisations for quality management needs.

Pros:

• Widely recognised: Familiar to many organisations, with strong integration into the Microsoft ecosystem.
• Highly customisable: Can be adapted to meet specific needs if you have the technical resources.
• Collaboration tools: Built-in tools for sharing, communication, and document access across teams.

Cons:

• Complex setup: Requires significant configuration to meet eQMS standards.
• Limited features: Does not inherently include core eQMS functions like CAPA, risk management, or audit trails.
• Costly over time: Customisation and maintenance often require external consultants or dedicated IT staff.
• User experience: Perceived as harder to configure and less intuitive than dedicated eQMS platforms.

Which eQMS is Right for You?

There’s no right answer to this question because every company’s needs are different. However, some eQMS companies are more suited to support scaling enterprises than others. If you are an innovative SME looking to shift quickly from paper or Google Docs to a digital platform, you should look for a solution that can be effectively right-sized to the way you work.

Using a proprietary eQMS platform is a good idea, compared to the effort of building a bespoke system with SharePoint - but you should beware the cost and complexity of using platforms built for larger enterprises if you are in growth mode.

Make sure your chosen system can scale with your needs and that you won’t be charged a fortune for features you’re not using