Reviewing the Top Medical Device Quality Software Options for 2020

    Times are changing and it’s getting harder and harder to keep up with ever-changing regulations using a paper-based quality management system. If you’re looking for a better solution, you aren't alone.

    Most regulatory bodies assume that you are already using a digital quality management system, and they have modified their requirements to suit their assumptions.

    If you’re a medical device manufacturer in the life sciences industry, then you are probably already feeling the pressure to switch away from paper and legacy systems and into a more streamlined approach.

    To help you make the best decision, we’ve compiled a list of some of the best medical device quality software providers in 2020.

    The Best Medical Device Quality Software Options 2020 Reviewed

    As the leading quality management platform for young and growing life sciences companies, we understand that you need to consider all of your options before making such a big leap. Changing systems is a significant investment in resources and you need to make sure you’re making the right decision.

    We routinely help customers decide if Qualio is the right fit for them. We don’t shy away from tough questions (check out our 12 Questions to Ask Before You Buy an eQMS) and we’re happy to guide people to the right company — even if it isn’t us. Our medical device quality software works best for startups and scale-ups with 5-500 employees. The pillars of our software are ease of use, scalability, and flexibility, which are what these companies need. But that might not be the best fit for your organization.

    We’ve compiled this list based on three factors: ability to meet the needs of a medical device company, quality of reviews available online, and longevity of the company.

    To be neutral, we’ve left ourselves off this list.

    The best medical device software options in 2020 (in no particular order), include:


    Trackwise is an enterprise-level quality management software that is produced by Sparta Systems.

    Insights from G2 Crowd:

    Rating is 3.9 out of 5

    Most Helpful Review: "It works"

    What do you like best? I like that it gives you the ability to record why you changed or added any information, sometimes this isn't required but when something has changed or a deadline has been pushed, it's helpful to record why some of those things happened.
    What do you dislike? There are a number of different records that are created as you move through the process of closing a non-conformance, it can be difficult at times to track back to the beginning.
    What problems are you solving with the product? What benefits have you realized? Helped close a number of CAPA's and had emailed reminders when things were close to being due to keep everything on track.
    - User, Enterprise (10,001+ employees)

    Master Control

    MasterControl is designed for mature life sciences companies that have a huge system to run and a large budget to run it with.

    Insights from G2 Crowd:

    Rating is 3.8 out of 5

    Most Helpful Review: "Easy to use, but could use some fixes."

    What do you like best? It's good for everyone's easy access to company documents. It keeps everything organized and allows departments to sign off on document changes in a quick manner.
    What do you dislike? It only works with Internet Explorer and it is very slow loading. You have to be exact in your search or it will say no results. For instance our document titles include a space and if the space is not included then there will be no returned search results.
    What problems are you solving with the product? What benefits have you realized? We're allowed to review documents quickly and fix mistakes in a timely manner. It's benefited us by allowing easier access to documents allowing us to print what we need when we need it.
    - User in Biotechnology, Enterprise Company (10,001+ employees)


    Qualsys is a quality management system based out of the UK that’s designed for “the world’s largest organizations with the most complex compliance requirements.”

    Insights from G2 Crowd:

    Rating is 5 out of 5

    Only Review: "Great tool for pharmaceutical industries."

    What do you like best? Customer requirements achieved to the production, of products that meet their standards hence greater satisfaction achieved leading to high profit making to the company.
    What do you dislike? The system may sometimes run slowly hence leading to inconveniency.
    Recommendations to others considering the product: Fast and efficient system.
    What problems are you solving with the product? What benefits have you realized? Prepare QMS deployment plan, Gap assessment, documentation, production of quality products achieved because there is need to comply with standard operating procedures.
    - Jackline O, Head Of Quality Control, Pharmaceuticals

    ETQ Reliance

    ETQ Reliance is designed for mid-sized up to enterprise-level companies across all industries.

    Insights from G2 Crowd:

    Rating is 4.1 out of 5

    Most Helpful Review: “Nexus”

    What do you like best? Very easy to learn. Great program when it wasn’t crashing.
    What do you dislike? Easy to get lost in it, especially in the version mars used. Too much going on, crashed often for long periods of time
    What problems are you solving with the product? What benefits have you realized? Great cross functionality, easy to connect multiple documents together
    - Carolyn T, Quality specialist - research and development


    UniPoint is an ERP-Integrated quality management software that was founded in 1996 as an ERP implementation and consulting company.

    Insights from G2 Crowd:

    Rating is 3.5 out of 5

    Most Helpful Review: "Unipoint is a Great Tool for Quality Control"

    What do you like best? The organization of the files for inspection makes it easy to find the model number. Also, Quality reports can be attached to the inspection record for review.
    What do you dislike? Unipoint is a great tool, but the navigation is not the most user-friendly. When I first started using Unipoint, it took me almost 3 days to figure out how to search for inspection records.
    Recommendations to others considering the product: Sit with someone and have them teach you how to navigate each field.
    What problems are you solving with the product? What benefits have you realized? Organizing all of our Quality reports from suppliers to keep up to date quality inspection records.
    - Rob F, Engineering Services Coordinator, Consumer Goods, Mid-Market(201-500 employees)

    How to Find the Right Quality Software for Your Medical Device Company

    Choosing the right eQMS system for you is not an easy decision and it’s definitely one that shouldn’t be rushed. The right quality software will fit both your long-term goals and serve your immediate needs.

    You need to consider how much customization you’ll need, what features you’ll utilize, how well it will scale with you, and how much support you’ll have access to during the implementation.

    Take the time to research your options:

    1. Read reviews from neutral third-party sites like G2 Crowd.
    2. Ask the company for references and talk with existing and past customers.
    3. Schedule demos with vendors and let them show you the system.
    4. Get hands-on and try them out yourself before making a commitment.
    5. Get your team involved and get buy-in from the people that will be using it every day.
    6. Make a list of the features that you need and rank them by priority.

    We aren’t the best fit for everyone, but we might be the right fit for you.

    We believe that we are the best eQMS for growing life sciences companies. Don’t take our word for it — take the time to read our reviews on G2 Crowd. Our customers share these recommendations to other people like you that are considering moving to Qualio:

    • Vanessa’s posted a helpful video review where she says, “If you’re working in a paper-based QMS system, Qualio really is a much better alternative. And if you’re considering it, I would definitely log on, look at some of their free tutorial videos and see how easy it is to use. They also have a number of references to call to ask them what their experience has been, how easy it is to get started, how is it is to get trained, and how easy it is to implement.”
    • MM said, “Try it! You will not be disappointed!”
    • Laura A said, “Get a demo and ask to use some real life documents. It is well worth checking out and you can call me with any questions !!”
    • Mid-Market User said, “Qualio is continuing to grow in their offerings and system functionality; if you see something that you wish it did but it does not, don't turn away! Qualio is very open to user feedback, holds regular business review meetings with their customers, and we have seen first hand their implementation of a change that we requested. They are very customer service oriented and very focused on continuing to update their application to increase functionality while keeping it 'simple' which any business can benefit from.”

    If you think Qualio might be a good fit and you want to explore our software more thoroughly, Schedule a Demo and let’s talk. There’s no obligation, no sales pitch, and no cost — just answers and helpful advice.