Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
About qmsWrapper
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
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qmsWrapper Frequently Asked Questions
qmsWrapper Product Features
CAPA
Quality Management
qmsWrapper Verified User Reviews
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Very nice software" Edited 2024-07-03
Pros: 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.
Cons: Sometimes you need to refresh the page for updates to show
Overall: 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.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"qmsWrapper review: Quality - high level" Posted 2023-07-17
Pros: Robust process engine automates workflows, minimizing errors and improving efficiency.
Responsive development team actively listens to user feedback and implements requested features.Cons: Primarily designed for small and medium-sized companies, limiting functionality for larger enterprises.
Overall: 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.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Easy managing" Posted 2023-06-26
Pros: 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.
Cons: Sometimes slow, but regardless, I can work without interruption.
Overall: I suggest everyone, you can try it for free. Everyone in the company will find features that will suit their needs.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Quality Management Software - qmsWrapper - Review" Posted 2023-06-16
Pros: 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.
Cons: 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.
Overall: I would recommend all companies to try qmsWrapper (14 days free) and decide for themselves whether it suits their needs.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Complete software for QMS" Posted 2022-12-30
Pros: 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.Cons: 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.
Overall: It's helped us become more efficient in our ability to manage documentation and all projects in our company.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Modules adaptable to any organization. I recommend qmsWrapper." Posted 2022-12-30
Pros: The whole company functions more smoothly.
Robust Document Management Module. Document control makes compliance easier for the team.
Free web templates (ISO 9001:2015).Cons: So far, I have no complaints about the software. Support is great.
Overall: Everything related to managing documentation.
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Collecting data for specific statistics that I create is much easier than before. -
Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Good platform for managing project and documentations. " Posted 2022-12-28
Pros: Great for managing all kind of projects (not just related to Quality). Documentations are easy to manage: approvals, revision history, organization in folders, etc.
Cons: I am not using all modules, so it would be good if we could "hide" some modules that we don't need.
Overall: Better organization, managing projects, and work with the team is easier than before. It is perfect for small companies.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Great for MedDev startups" Posted 2022-11-07
Pros: 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.
Cons: The system is complicated for those who have never used software of this type.
Overall: 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.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Traceability Matrix is the best dashboard" Posted 2020-01-21
Pros: 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.
Cons: Some bugs are showing, but they are fixing that. And sometimes it is slow.
Overall: I would suggest to all startups from medical industry. It is very useful tool for QMS.
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Probability You Would Recommend?1 2 3 4 5 6 7 8 9 10
"Very satisfied" Posted 2019-12-30
Pros: Best Traceability Matrix, easy to use.
New Risk Module is very helpful with added questions.Cons: Sometimes you need to refresh the page to show up your updates. It is slow sometimes.
Overall: I would recommend this software to all startups. It can help you with your submission. The support team is very helpful.
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