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qmsWrapper Description

qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.

Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.

Pricing

Pricing Starts At:
€3,499
Pricing Information:
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial:
Yes

Integrations

Reviews - 11 Verified Reviews

Total
ease
features
design
support

Company Details

Company:
qmsWrapper
Headquarters:
Canada
Website:
www.qmswrapper.com
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Media

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Product Details

Platforms
Web-Based
Windows
Mac
Linux
Types of Training
Training Docs
Live Training (Online)
Training Videos
Customer Support
Online Support

qmsWrapper Features and Options

Quality Management Software

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management

CAPA Software

Audit Management
CAPA Planning
Change Management
Complaint Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
  • Name: Maria L.
    Job Title: Regulatory Affairs Manager
    Length of product use: 1-2 Years
    Used How Often?: Weekly
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Makes QMS work much easier to manage

    Date: Oct 07 2026

    Summary: Overall, it has made managing QMS activities much easier. What I find most useful is that everything is connected, so you don't have to keep jumping between different tools or manually keep track of related records. It has also improved quite a lot over time, with new features being added regularly.

    Positive: I like having documents, training, CAPAs, risks and other QMS activities in one place. It saves a lot of time compared with working across different files and tools, and it is much easier to see how things are connected. I also like that the system is flexible and we can adjust processes when needed.

    Negative: There is a bit of a learning curve at the beginning because there are a lot of features. Some areas could also be a little more intuitive, but once you get used to the system, everyday work becomes quite straightforward.

    Read More...
  • Name: Bojan M.
    Job Title: Marketing
    Length of product use: 2+ Years
    Used How Often?: Daily
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Very nice software

    Edited: Jul 03 2024

    Summary: I recommend qmsWrapper to all small and medium-sized companies because it is a great solution for handling QMS. The price is affordable, and the support is great. It significantly improves organization, project management, and team collaboration.

    Positive: I love the interface and the helpful dashboard that reminds you daily of tasks related to you. The Quality Manual is editable and free to use, making it very user-friendly. Custom templates, notifications, automation, and risk management features are ideal for small and medium-sized companies. The technical support is excellent, answering all our questions quickly and accurately. If we need additional explanation, they are happy to schedule video training for us. Additionally, it's great for managing all kinds of projects, not just those related to quality. Documentation management, including approvals, revision history, and organization in folders, is straightforward. The Traceability Matrix is the best I've seen and very easy to use. The new Risk Module is very helpful with its added questions.

    Negative: Sometimes you need to refresh the page for updates to show

    Read More...
  • Name: Stephan R.
    Job Title: Audit and Training Manager
    Length of product use: 1-2 Years
    Used How Often?: Daily
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Quality Management Software - qmsWrapper - Review

    Date: Jun 16 2023

    Summary: I would recommend all companies to try qmsWrapper (14 days free) and decide for themselves whether it suits their needs.

    Positive: qmsWrapper is an exceptional QMS software that has transformed our quality management processes. The software is intuitive and the modules are meticulously designed. The traceability matrix capability provides valuable insights into the relationships between requirements, tests, and other project elements, enhancing overall quality and compliance.

    Negative: While qmsWrapper offers impressive features, some users may experience slight slowness in the software's performance. However, this minor issue does not significantly impact its overall functionality or hinder the effectiveness of the quality management processes.

    Read More...
  • Name: Marko P.
    Job Title: Developer
    Length of product use: 2+ Years
    Used How Often?: Daily
    Role: User
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Complete software for QMS

    Date: Dec 30 2022

    Summary: It's helped us become more efficient in our ability to manage documentation and all projects in our company.

    Positive: It is user-friendly software, flexible, and can be integrated if you are a Jira user. It is especially intended for small companies that need a QMS.

    Things that I like and use daily: tasks, document approval, sending doc for review, creating new forms (managing forms), team chat for meetings, and daily conversations.

    Negative: What I don't like is that it is aimed at small companies because I feel that this kind of software would be very useful for companies that have 100+ employees. They should develop in that direction.

    Read More...
  • Name: Nadia N.
    Job Title: Marketing Consultant
    Length of product use: 1-2 Years
    Used How Often?: Daily
    Role: User
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Modules adaptable to any organization. I recommend qmsWrapper.

    Date: Dec 30 2022

    Summary: Everything related to managing documentation.

    Collecting data for specific statistics that I create is much easier than before.

    Positive: The whole company functions more smoothly.

    Robust Document Management Module. Document control makes compliance easier for the team.

    Free web templates (ISO 9001:2015).

    Negative: So far, I have no complaints about the software. Support is great.

    Read More...
  • Name: Ivon D.
    Job Title: Clinical Data Associate
    Length of product use: 1-2 Years
    Used How Often?: Daily
    Role: User
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Good platform for managing project and documentations.

    Date: Dec 28 2022

    Summary: Better organization, managing projects, and work with the team is easier than before. It is perfect for small companies.

    Positive: Great for managing all kind of projects (not just related to Quality). Documentations are easy to manage: approvals, revision history, organization in folders, etc.

    Negative: I am not using all modules, so it would be good if we could "hide" some modules that we don't need.

    Read More...
  • Name: Hajnalka F.
    Job Title: QMS Manager
    Length of product use: 2+ Years
    Used How Often?: Daily
    Role: User, Administrator
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Great for MedDev startups

    Date: Nov 07 2022

    Summary: I recommend qmsWrapper to all small and medium-sized companies because it is a great solution to handle QMS. The price is affordable, and support is great.

    Positive: I love the interface and the helpful dashboard that reminds you daily of tasks related to you. Quality Manual is editable and free to use - easy to use. Custom templates, notifications, automation, risk, etc., are ideal for small and medium-sized companies. The technical support answers all our questions quickly and accurately, and if we need additional explanation, they will be happy to schedule a video training for us.

    Negative: The system is complicated for those who have never used software of this type.

    Read More...
  • Name: Anonymous (Verified)
    Job Title: Marketing manager
    Length of product use: Less than 6 months
    Used How Often?: Daily
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Traceability Matrix is the best dashboard

    Date: Jan 21 2020

    Summary: I would suggest to all startups from medical industry. It is very useful tool for QMS.

    Positive: From the Traceability Matrix, we can easily manage and track your design development. Processes for ISO13485 are included. Easy to make tasks and follow their status.

    Negative: Some bugs are showing, but they are fixing that. And sometimes it is slow.

    Read More...
  • Name: Melese S.
    Job Title: Product Manager
    Length of product use: 2+ Years
    Used How Often?: Daily
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    qmsWrapper review: Quality - high level

    Date: Jul 17 2023

    Summary: qmsWrapper offers a comprehensive solution for quality management, with a powerful process engine and a responsive development team. While it caters primarily to small and medium-sized businesses, its automation capabilities and commitment to user feedback make it a valuable tool for streamlining operations.

    Positive: Robust process engine automates workflows, minimizing errors and improving efficiency.
    Responsive development team actively listens to user feedback and implements requested features.

    Negative: Primarily designed for small and medium-sized companies, limiting functionality for larger enterprises.

    Read More...
  • Name: Anonymous (Verified)
    Job Title: Project manager
    Length of product use: 6-12 Months
    Used How Often?: Daily
    Role: User
    Organization Size: 26 - 99
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Easy managing

    Date: Jun 26 2023

    Summary: I suggest everyone, you can try it for free. Everyone in the company will find features that will suit their needs.

    Positive: Managing with qmsWrapper is easy, I am using it to organize my department. The team works easily and everything is recorded in detail in the system.

    Negative: Sometimes slow, but regardless, I can work without interruption.

    Read More...
  • Name: Maria N.
    Job Title: Manager
    Length of product use: Less than 6 months
    Used How Often?: Daily
    Role: User
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Very satisfied

    Date: Dec 30 2019

    Summary: I would recommend this software to all startups. It can help you with your submission. The support team is very helpful.

    Positive: Best Traceability Matrix, easy to use.
    New Risk Module is very helpful with added questions.

    Negative: Sometimes you need to refresh the page to show up your updates. It is slow sometimes.

    Read More...
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