qmsWrapper 2026: Benefits, Features & Pricing

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Overview
Pricing and Plans
Features
Integrations
User Reviews

Overview

qmsWrapper

4.6

(15)

Pricing

Pricing available upon request

About qmsWrapper

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:

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.
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 Mat...

qmsWrapper Screenshots

qmsWrapper Pricing and Plans

Starting price: Connect with an advisor for pricing

Free Trial

Free Version

Medical Devices: Starter 10

Pricing available upon request

No plan information available

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qmsWrapper Features

Popular features found in Quality Management
Change Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Management
Electronic Signature
Incident Management
Quality Control
Risk Management
Task Management
Training Management
More features of qmsWrapper
Audit Management
Collaboration Tools
Communications Management
Compliance Management
Customizable Reports
Document Coding & Control
Equipment Management
ISO Standards Management
Maintenance Management
Nonconformance Tracking
Project Planning/Scheduling
Real-Time Updates
Reporting/Project Tracking
Reporting & Statistics
Risk Assessment
Root Cause Analysis
Supplier Quality Control
Task Progress Tracking

qmsWrapper Integrations

Jira

qmsWrapper User Reviews

Overall Rating

4.6

Ratings Breakdown

80%

13%

Secondary Ratings

Ease of Use

4.2

Value for money

4.5

Customer support

4.8

Functionality

4.1

Jonathan E.

Medical Devices

2-10 employees

Used daily for less than 6 months

Review source

Reviewed September 2017

Very happy to have found, even happier to recommend!

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

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Karen M.

Verified reviewer

Medical Devices

11-50 employees

Used daily for more than 2 years

Review source

Reviewed December 2020

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

Reasons for choosing qmsWrapper

The qmsWrapper is selected based on the possibility to create your own modules for recording (not just quality) events.

Metehan A.

Verified reviewer

Medical Devices

51-200 employees

Used monthly for free trial

Review source

Reviewed December 2020

Outdated Software

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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

Vendor Response

We appreciate your feedback. We are pleased that we were of help to you while being on the free trial but sad to hear you haven't given it a chance in a proper way. Regards the spreadsheets, they are only used in TM that is used for design controls and made for those ones who prefer to lead their projects in them. And we cannot emphasize enough, that qmsWrapper is more than just software for QMS maintenance because it gives you an opportunity to create your own modules according to your needs. As many modules you want, on the way you want it. Even it might look outdated, it follows the most up to date management systems and having robust document management by the standard. Plus, we do support integration with Jira. If you need any further help we are here to your assistance. Don't hesitate to get in touch with us by email at contact@qmswrapper.com

Replied December 2020

Paddy M.

Verified reviewer

Medical Devices

2-10 employees

Used weekly for less than 12 months

Review source

Reviewed May 2021

A complete beginner ...

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.

Ratings Breakdown

Ease of use

Customer support

Functionality

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.

Reasons for choosing qmsWrapper

Good price and look and feel.

Vladimir N.

Verified reviewer

Medical Devices

11-50 employees

Used daily for less than 2 years

Review source

Reviewed November 2022

Quality Management Software review

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.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

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.

hajnalka f.

Verified reviewer

Medical Devices

11-50 employees

Used daily for more than 2 years

Review source

Reviewed November 2022

qmsWrapper review

Easy to use, helps me to handle all events in the company.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Easy QMS implementation with qmsWrapper. Free process templates (editable) to use. We also create a new (our own) processes, and issues to collect some data. We are managing all projects from our company in qmsWrapper.Support is great.

Cons:

Slow system sometimes, but that is not a big problem to our company.

Reasons for choosing qmsWrapper

Because of the features, and price.

Bill M.

Verified reviewer

Medical Devices

51-200 employees

Used daily for less than 12 months

Review source

Reviewed December 2020

Very pleased with the software.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Document management is crucial for my department. But I have to mention, that we are using qmsWrapper not only for QMS, which pleased very much our needs. eSignatures for document approval is something that made us definitely say yes to the software, besides all other features and their price. They may even be a little unrealistically cheap, but if it suits them that way, it suits us as well.

Cons:

In the very beginning, we struggled a bit with its use, but with their 'how-to' documentation, and all other instruction, and wonderful customer support, it became a tool it's hard to live without. Some of our employees said it's not intuitive enough, but I would say it's not on the first ball.

Louis W.

Verified reviewer

Medical Devices

11-50 employees

Used daily for more than 2 years

Review source

Reviewed May 2020

Innovation meets quality

I am very satisfied with it and definitely I would recommend it to my colleages and people out there involved with the medical device industry.

Ratings Breakdown

Ease of use

Value for money

Functionality

Pros:

I really like the newest version of the software as it allows me and my team to go through the six modules easily. Definitely we can organize better, trace efficiently and manage all our documentation and more.

Cons:

I don´t have any complaints by far about the software. I think is the opposite, it allowed us to have a high quality software that allowed us to get through our FDA submission easily and more efficient than any other software we have used before.

Bryan B.

Verified reviewer

Information Technology and Services

11-50 employees

Used weekly for less than 6 months

Review source

Reviewed December 2020

Excellent Intuitive software

Good experience

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Ease of use, not complicated, good overview of projects and tasks

Cons:

Perhaps integration and maintenance of the Technical file, would also be useful if ISO14971 aspects would be integrated.

Vendor Response

Hi, Bryan, We really appreciate your feedback. Regarding the ISO 14971 aspects integration, qmsWrapper has an integrated Risk Management Module, that is built based on ISO 14971 guidance and it's combined with a flexible system where you can create your own Risk processes, including approval workflows, and define risk varieties and action plans. qmsWrapper also lets you build a Traceability Matrix for all your medical device regulatory needs. It is the cornerstone of the DHF or CE Technical File. It supports linked documents in storage and allows you to use qmsWrapper's customizable forms to create custom verification and validation testing documents that will link, track, and show the connections between each. Also, you can include the reference to each identified hazard in the Risk Management Module, and directly link them in your Technical File matrix. Please, get in touch if you have more questions regards this matter. We are happy to help. Greetings from qmsWrapper team.

Replied January 2021

Emma F.

Verified reviewer

Medical Devices

11-50 employees

Used daily for more than 2 years

Review source

Reviewed July 2019

Recommend this software

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

I love that they have a good Tractability Matrix that helps our company a lot. Every document is on right place and no more loosing files and problems when it goes to approve. Also, the support team is very kind and always helping when we need some questions.

Cons:

We are using this software many years and I don't have any objection about it.

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