qmsWrapper: The best Solution for Quality Management System

Create

any project

successfully!

Control your

submission

documentation.

Ensure

regulatory

compliance.

ISO 13485, CE Mark

21 CFR Pt.11, 21 CFR 820,

FDA 510k.

More than +500 companies trusted
qmsWrapper with their QMS.

Elevate Your Quality Management
with qmsWrapper

qmsWrapper provides powerful tools to manage critical quality processes, including CAPA, Nonconformity, Training, Change Management, Supplier Management, and Feedback. Our robust modules—Project Management, Quality Management, Document Management, Team Communication, Traceability Matrix, and Risk Management—are designed to enhance compliance and operational efficiency.

qmsWrapper integrates seamlessly into your workflow, allowing for consistent oversight and control across all quality processes. Whether you're handling routine tasks or addressing complex challenges, our platform supports your team every step of the way, ensuring nothing falls through the cracks.

Louis W.

Medical device specialist

Definitely, we can organize better, trace efficiently and manage all our documentation and more. I am very satisfied with it and definitely I would recommend it to my colleagues and people out there involved with the medical device industry.

Jonathan E.

QMS Associate

It builds us a quality manual based on our specific requirement, shows us what processes to implement in order to adhere to said manual, walks us through those processes using project management methodologies, and even gives us the templates we need to populate to be compliant.

Anders B.

Head of Operations

Once again, I just must stress how happy I am that you have managed to find a solution to “preview” a word document without the need to first download. This is such a huge help!
So, thank you! We highly recommend it.

Rosallia R.

Quality Engineer

Overall experience is rather positive for the modules that we use. Being a small start-up company, having ISO 134185 to maintain and CE and FDA pending, we are quite happy how we use this software. For the future, we hope they will have more features that will aid us, such as custom forms, so we could completely transfer our work there instead of having to go back and forth between Word and software.

Bartek L.

QMS Associate

One of the things that we really like is that, in the Storage you can see all the information on one particular document – who created, number of revisions, changes, authors of revision, when it was reviewed, approvals, even the comments why the revision was declined. It takes a lot less time for showing the auditors what we did – one click to the designated folder and you have your ISO13485 required information for that document. Talking about the document control…

Reliable

Trustworthy software to use - validated
according to ISO/TR 80002-2

Easy to implement and use

Out-of-the-box ready for use with
included default SOP templates and
workflow processes.

Fully Scalable

Implement the modules at your own
place, so your quality system can grow
with your team.

Choose your eQMS

eQMS for MedDev ISO 13485

qmsWrapper is an affordable and unique solution for start-up and small-sized companies involved in the medical device industry. qmsWrapper is envisioned as a tool to facilitate the implementation of a quality management system by establishing document control management, design controls, risk management, and other activities related to quality.

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eQMS ISO 9001

qmsWrapper is envisioned as a tool to facilitate the implementation of quality management systems by offering different features, such as document control management, electronic signature, design controls, risk management module, and many more. We believe in MTQ (Management through quality) where anyone can tailor each project to fit each individual business. qmsWrapper, as best-in-class, can provide result-orientated collaborative QMS compliance since it designed to help electronically implement and maintain ISO 9001 compliance activities.

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Tailored Features
for Your Industry Needs

At qmsWrapper, we understand that each industry has its unique quality management requirements. That's why our software offers a range of features tailored to meet the needs of businesses operating in different sectors:

Compliance Made Easy: Ensure compliance with industry standards such as ISO 13485 for medical devices and ISO 9001 for general quality management. qmsWrapper helps you establish and maintain a robust quality management system that meets regulatory requirements effortlessly.
Risk Management Simplified: Simplify risk assessment and management processes with our integrated tools, ensuring compliance with standards like ISO 14971 for medical devices. Identify, assess, and mitigate risks effectively to protect your products and reputation.
Document Control: Maintain complete control over your documents with our intuitive document management system. Organize, review, and approve documents with ease, enhancing document traceability and version control.
Cloud-Based Accessibility: Access your quality management system anytime, anywhere with our cloud-based platform.
Electronic QMS: Say goodbye to paper-based processes and embrace the efficiency of electronic quality management. qmsWrapper digitizes your QMS, allowing for faster approvals, real-time updates, and much more.
Audit Management: Prepare for audits with confidence using qmsWrapper's audit management tools. Schedule audits, track findings, and generate comprehensive reports to demonstrate compliance.