--- description: Review of qmsWrapper Software: system overview, features, price and cost information. Get free demos and compare to similar programs on Software Advice Ireland. image: https://gdm-localsites-assets-gfprod.imgix.net/images/software_advice/og_logo-55146305bbe7b450bea05c18e9be9c9a.png title: qmsWrapper | Reviews, Pricing & Demos - SoftwareAdvice IE --- Breadcrumb: [Home](/) > [Online Project Management Software](/directory/436/web-based/software) > [qmsWrapper](/software/32544/qmswrapper) # qmsWrapper Canonical: https://www.softwareadvice.ie/software/32544/qmswrapper Page: 1 / 2\ Next: [Next page](https://www.softwareadvice.ie/software/32544/qmswrapper?page=2) > qmsWrapper is a unified, AI-powered Quality Management System designed specifically for medical device and SaMD companies. It supports compliance with ISO 13485, ISO 14971, FDA 21 CFR Part 820 \& Part 11, ISO 9001, and EU MDR, while connecting quality, design, and risk processes into a single, coherent platform. Unlike fragmented QMS setups, qmsWrapper is built on a connected architecture that reflects how medical device organizations actually work. At its core are two interlocking systems: 1. Quality Event System (QES) The QES is the event-driven engine that captures and manages everything that deviates from plan or triggers improvement. It handles nonconformities, deviations, CAPAs, changes, audit findings, feedback, and post-market events through structured, auditable workflows. Events are classified, routed, and tracked from creation to closure, with full visibility into status, responsibilities, and decision history. 2. Design History System (DHS) The DHS is the proactive design control framework supporting the Design History File (DHF/DTF). It connects use cases, requirements, risks, design inputs and outputs, and verification \& validation tests into a live Traceability Matrix. This ensures that every design decision is traceable, defensible, and continuously aligned with risk management and quality events. AI Assistance – Built for Practical Compliance AI in qmsWrapper is designed to support, not replace, human decision-making. It assists users by: - helping complete forms faster using contextual suggestions - automatically linking related records across QES and DHS - enabling semantic search across events, documents, risks, and traceability data All outputs remain fully user-controlled, reviewable, and auditable, ensuring regulatory safety and transparency. End-to-End Visibility and Audit Readiness qmsWrapper provides real-time dashboards and logs that show open items, overdue actions, approvals, and workflow progress. Audit readiness becomes part of daily operations rather than a last-minute effort. Every record, change, and approval is timestamped and traceable. Complete QMS in One Platform qmsWrapper includes document control, training management, supplier management, risk management, CAPA, change control, project management, and team collaboration—all modules included in one transparent price. There are no hidden add-ons or feature gates as your organization grows. Built for MedTech Teams Validated, secure, cloud-based, and GDPR-compliant, qmsWrapper is designed for fast implementation and high adoption in MedTech SMEs. Teams can go live in weeks, not months, without large IT projects or heavy consulting dependency. From early design and development through audits and post-market surveillance, qmsWrapper helps medical device companies reduce manual work, improve consistency, maintain defensible traceability, and stay compliant throughout the entire product lifecycle. > > Verdict: Rated **4.6/5** by 15 users. Top-rated for **Likelihood to recommend**. ----- ## Quick Stats & Ratings | Metric | Rating | Detail | | **Overall** | **4.6/5** | 15 Reviews | | Ease of Use | 4.2/5 | Based on overall reviews | | Customer Support | 4.8/5 | Based on overall reviews | | Value for Money | 4.5/5 | Based on overall reviews | | Features | 4.1/5 | Based on overall reviews | | Recommendation percentage | 80% | (8/10 Likelihood to recommend) | ## About the vendor - **Company**: qmsWrapper - **Location**: Markham, Canada - **Founded**: 2015 ## Commercial Context - **Pricing model**: Per User - **Pricing Details**: qmsWrapper is offered as a subscription-based, all-in-one QMS platform designed for medical device and SaMD companies that need predictable pricing and full functionality from day one. The pricing model is simple and transparent, with all core QMS capabilities included in every subscription. There are no feature tiers, hidden modules, or mandatory upgrades as your quality system matures. The subscription provides full access to the Quality Event System and Design History System, including a live Traceability Matrix supporting the DHF/DTF. It also includes document control with electronic approvals, risk management aligned with ISO 14971, CAPA and change control workflows, audit and deviation management, training and supplier management, project management, team collaboration, dashboards, logs, and complete audit trails. AI-assisted form completion, automatic record linking, and semantic search across quality and design data are included as part of the platform, not as add-ons. Pricing is based on annual per-user licenses, allowing organizations to scale gradually as teams grow. Each licensed user has access to the full platform functionality, with configurable permissions to support different roles such as quality, engineering, management, or auditors. This ensures that all relevant stakeholders can participate in the QMS without functional limitations. qmsWrapper is designed to be accessible for MedTech startups and growing companies while meeting enterprise-grade regulatory requirements. Customers are not required to purchase large upfront implementation packages or ongoing consulting services to achieve compliance. The system is pre-configured for ISO 13485, FDA 21 CFR Part 820 and Part 11, ISO 14971, and EU MDR, enabling most teams to go live in weeks rather than months. AI functionality is included in the subscription at no additional cost. AI supports users by reducing manual data entry, improving consistency across records, and helping teams quickly locate relevant information. All AI-generated assistance remains fully user-controlled, reviewable, and auditable to ensure regulatory safety and transparency. As organizations expand their product portfolio or regulatory scope, qmsWrapper scales without forcing migrations to new systems or changes to the pricing model. This protects long-term investment in the QMS and ensures continuity throughout the entire product lifecycle. Pricing depends on the number of users and subscription term, and tailored quotes are available upon request. - **Target Audience**: Self Employed, 2–10, 11–50, 51–200, 201–500, 501–1,000 - **Deployment & Platforms**: Cloud, SaaS, Web-based, Mac (Desktop), Windows (Desktop) - **Supported Languages**: English - **Available Countries**: Austria, Belgium, Canada, Czechia, Denmark, Finland, France, Germany, India, Ireland, Italy, Liechtenstein, Lithuania, Luxembourg, Netherlands, Norway, Pakistan, Poland, Portugal, Serbia and 6 more ## Features - Audit Management - Change Management - Collaboration Tools - Communications Management - Complaint Management - Compliance Management - Corrective and Preventive Actions (CAPA) - Customisable Reports - Defect Tracking - Document Coding & Control - Electronic Signature - Equipment Management - ISO Standards Management - Incident Management - Maintenance Management - Nonconformance Tracking - Project Planning/Scheduling - Quality Control - Real-Time Updates - Reporting & Statistics ## Integrations (1 total) - Jira ## Support Options - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - Chat ## Category - [Online Project Management Software](https://www.softwareadvice.ie/directory/436/web-based/software) ## Related Categories - [Online Project Management Software](https://www.softwareadvice.ie/directory/436/web-based/software) - [Project Management Software for Small Business](https://www.softwareadvice.ie/directory/3618/small-business/software) - [Nonprofit Project Management Software](https://www.softwareadvice.ie/directory/3863/nonprofit/software) - [Manufacturing Project Management Software](https://www.softwareadvice.ie/directory/4062/manufacturing/software) - [Quality Management Software](https://www.softwareadvice.ie/directory/420/quality-management-software/software) ## Alternatives 1. 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For a long time we have to run project management separately in Asana, increasing our workload and, even after expensive MasterControl training, leaving us wondering what to do to get our medical device through the certification process. Then I found QmsWrapper QmsWrapper is not only a QMS system and a Project Management tool, but it actually has the processes and templates required to get you through ISO 13485 and an FDA510k build directly into it. This was clearly made by people who have not only been through the process, but recognised how hard it was and the need for a system to help guide one through it. Their support reflects this, as they understand your needs and go above and beyond helping you. The processes explain what you need to do, step by step, giving you templates to download, populate, and upload back into the system. Auditors don't just want to see that you have said you are going to do something, they want proof that you have done it - using QmsWrapper to do your project management, host your meetings, and have conversations in its inbuilt chat program, provide you with just that - proof. It even has an inbuilt quality manual that you configure to your companies needs. You can then run a gap analysis from what you have said you're going to do, and what you have actually done, to find the holes. > > **Cons**: They need a new desktop sync tool, which I believe they are working on, but the biggest issue with the system is that it does not interface with your local calendar. Meetings have to be scheduled all the time, with people on the go, and one must consider that the entire team does not sit in the system. It could also do with a traceability matrix, and better training videos / manuals. My account manager has been fantastic in lieu of this, and I have it on good faith that the matrix is on its way this month. > > Project management + QMS Processes to guide you through regulations Templates to populate Massively cost saving Wonderful account management Automated Quality Manual with a gap analysis report ----- ### "QA" — 5.0/5 > **Karen** | *14 December 2020* | Medical Devices | Recommendation rating: 7.0/10 > > **Pros**: For my job it is quite important to keep track of all documentation, including regulatory submissions. In the Storage you can see all the information on one particular document – who created, number of revisions, changes through revisions, who was the author of revision, when it was reviewed, when and which revision is approved, even the comments why the revision was declined. It takes a lot less time for showing the auditors what we did. > > **Cons**: It was a bit time consuming setting the system, and to understand what is the best way to organize our work. > > I admit, at the beginning, I was a bit reluctant when it came to using it, since we previously used paper-based system. But, slowly, I got to a point where I was proud of myself for managing my work through it. ----- ### "Outdated Software" — 1.0/5 > **Metehan** | *9 December 2020* | Medical Devices | Recommendation rating: 0.0/10 > > **Pros**: Easy to understand, Helpful team, Quick response and availability > > **Cons**: The software is outdated, its like an improved excel sheet, We are using jira/confluence day to day basis and qms wrapper is not even matching with them ----- ### "A complete beginner ..." — 5.0/5 > **Paddy** | *4 May 2021* | Medical Devices | Recommendation rating: 8.0/10 > > **Pros**: As part of a very small startup medical device development company I was given the task of looking at compliance. While familiar with IT systems in general, I had zero QMS knowledge and experience, and indeed still coming to terms with the concepts and practice. At the start it would have been very helpful to have video tutorials and / or an overview diagram as to how the system works, but in their absence I ended up printing out the user manual and working my way through that and setting up a demo project to play with. I did come across a few bugs, but these were acknowledged when reported and hopefully addressed. When stumped, I had quick replies to any queries which was appreciated. From a purely IT perspective the level of integration and process / document control is impressive. > > **Cons**: I have started working on the quality manual "add-on", and while appreciating the approach being taken to use a template document integrated to the core product to permit an automated GAP report, the very limited word processing functionality in the design and amendment of the manual is for me a major issue, particularly as I am of an age where grammar matters and a document's look and feel is important. > > Coming from ground zero I think there needs to be more to help in getting started and in understanding the fundamental approach of qmsWrapper. Having said that, for someone with a little knowledge of quality management systems it may be much more intuitive. I am impressed with the level of integration and system stability, and apart from the odd minor change to programs from that which is documented in the Help Guide, I have not been able to break it yet. ----- ### "Quality Management Software review" — 5.0/5 > **Vladimir** | *8 November 2022* | Medical Devices | Recommendation rating: 9.0/10 > > **Pros**: Implementing the design controls and risk management activities is intuitive. qmsWrapper's Traceability Matrix helps us to develop device and to have Technical File with one click. When you have support like theirs, you don't have to worry about how your employees would accept working in software. > > **Cons**: When they have an upgrade, I often come across a bug that they fix in a few days. It really suits our needs and I can't single out bigger cons. > > I am satisfied with qmsWrapper, because it has all the necessary functionalities for successful management of QMS and product development. I would like to highlight that the organization in the company is much better than before. The price of the annual subscription is quite satisfactory. ----- Page: 1 / 2\ Next: [Next page](https://www.softwareadvice.ie/software/32544/qmswrapper?page=2) ## Links - [View on SoftwareAdvice](https://www.softwareadvice.ie/software/32544/qmswrapper) ## This page is available in the following languages | Locale | URL | | de | | | en | | | en-AU | | | en-GB | | | en-IE | | | en-NZ | | | fr | | ----- ## Structured Data