--- description: Review of qmsWrapper Software: system overview, features, price and cost information. Get free demos and compare to similar programs on Software Advice New Zealand. image: https://gdm-localsites-assets-gfprod.imgix.net/images/software_advice/og_logo-55146305bbe7b450bea05c18e9be9c9a.png title: qmsWrapper | Reviews, Pricing & Demos - SoftwareAdvice NZ --- Breadcrumb: [Home](/) > [Online Project Management Software](/directory/436/web-based/software) > [qmsWrapper](/software/32544/qmswrapper) # qmsWrapper Canonical: https://www.softwareadvice.co.nz/software/32544/qmswrapper Page: 1 / 2\ Next: [Next page](https://www.softwareadvice.co.nz/software/32544/qmswrapper?page=2) > qmsWrapper is an AI-enabled Quality Management System (QMS) designed specifically for medical device, SaMD and IVD companies that need a compliant, scalable platform without the complexity of traditional enterprise QMS solutions. Many growing companies begin with Word documents, spreadsheets, email approvals and shared folders. These tools may work initially, but as regulatory requirements increase, maintaining consistency, traceability and audit readiness becomes increasingly difficult. qmsWrapper was built around a different philosophy. Instead of forcing organizations to implement every quality process from day one, the platform grows with the company through three connected editions. Foundation establishes the operational backbone of the QMS by replacing disconnected documents and manual processes with controlled documents, electronic approvals, forms, training, tasks and AI-assisted quality management. Lifecycle expands Foundation into a connected quality and product lifecycle management system. CAPA, Change Control, Nonconformities, Complaints, Quality Events, ISO 14971 Risk Management, Supplier Quality, Technical Files and Smart Traceability become part of one integrated workflow where information is connected instead of isolated. Vigilance extends the platform beyond operational quality management into continuous regulatory oversight. It provides evidence-ready management across post-market surveillance, regulatory readiness, audit management, AI governance and organizational compliance. Every edition builds on the previous one. Organizations never lose what they have already implemented. There is no migration to another system, no rebuilding of processes and no need to replace the platform as the business grows. The platform is designed to support the complete quality lifecycle while maintaining human oversight over AI-assisted activities. AI can help prepare records, identify missing information, connect related evidence and assist with quality workflows, while regulated decisions always remain under qualified human responsibility. qmsWrapper supports organizations working with: • ISO 13485 • ISO 14971 • FDA QMSR • FDA 21 CFR Part 11 • EU MDR • EU IVDR The platform combines controlled documents, quality events, risk management, technical documentation, training, supplier quality, audit management, post-market surveillance and regulatory oversight within one connected environment. Unlike traditional enterprise QMS platforms that often require organizations to implement every module from the beginning, qmsWrapper allows companies to start where the need is greatest and expand gradually as regulatory maturity increases. This approach reduces implementation complexity while preserving complete traceability and audit evidence throughout the entire product lifecycle. Whether you are replacing paper-based processes, implementing your first compliant QMS or expanding an existing quality system to support growth, qmsWrapper provides a connected platform that evolves with your organization instead of forcing you to change platforms as your needs change. Start with Foundation. Grow with Lifecycle. Scale with Vigilance. > > 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 - **Starting Price**: €3,499.00 - **Pricing model**: Flat Rate - **Pricing Details**: qmsWrapper is available in three editions designed to grow with your organization. Start with Foundation to establish a controlled quality management system, expand to Lifecycle for connected quality and product lifecycle workflows, and extend to Vigilance for continuous regulatory oversight. Keep everything you build as your QMS evolves, no migration, no rebuilding. Foundation starts at EUR 3,499/year. Lifecycle and Vigilance are available on request. All editions include unlimited users and 1 GB of storage. Additional storage is available at USD 1.50 per GB/month. - **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 - AI Copilot - API - Access Controls/Permissions - Alerts/Notifications - Audit Management - Change Management - Collaboration Tools - Commenting/Notes - Communications Management - Complaint Management - Compliance Management - Corrective and Preventive Actions (CAPA) - Customisable Reports - Customisable Templates - Data Import/Export - Defect Tracking - Document Coding & Control - Document Management - Drag & Drop - Electronic Signature ## Integrations (1 total) - Jira ## Support Options - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - Chat ## Category - [Online Project Management Software](https://www.softwareadvice.co.nz/directory/436/web-based/software) ## Related Categories - [Online Project Management Software](https://www.softwareadvice.co.nz/directory/436/web-based/software) - [Project Management Software for Small Business](https://www.softwareadvice.co.nz/directory/3618/small-business/software) - [Manufacturing Project Management Software](https://www.softwareadvice.co.nz/directory/4062/manufacturing/software) - [Quality Management Software](https://www.softwareadvice.co.nz/directory/420/quality-management-software/software) - [Corrective and Preventive Action Software](https://www.softwareadvice.co.nz/directory/4713/capa/software) ## Alternatives 1. [Jira](https://www.softwareadvice.co.nz/software/4315/jira) — 4.4/5 (15457 reviews) 2. [Wrike](https://www.softwareadvice.co.nz/software/3777/wrike-pm) — 4.4/5 (3037 reviews) 3. [Zoho Projects](https://www.softwareadvice.co.nz/software/392421/zoho-projects) — 4.5/5 (870 reviews) 4. [ClickUp](https://www.softwareadvice.co.nz/software/123064/clickup) — 4.6/5 (4619 reviews) 5. [Smartsheet](https://www.softwareadvice.co.nz/software/157390/smartsheet) — 4.5/5 (3538 reviews) ## Reviews ### "Very happy to have found, even happier to recommend\!" — 5.0/5 > **Jonathan** | *6 September 2017* | Medical Devices | Recommendation rating: 10.0/10 > > **Pros**: My company came from MasterControl; we found it hard to use, expensive, and essentially a giant version control system that was quite dated. 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.co.nz/software/32544/qmswrapper?page=2) ## Links - [View on SoftwareAdvice](https://www.softwareadvice.co.nz/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