Smarter QMS for Medical Device Teams
Compliance-ready. Workflow-driven. Built for FDA, ISO 13485, and global regulations.
qmsWrapper combines quality management, project execution, and document control
into one validated platform—engineered for teams navigating FDA regulations,
ISO standards, and 510(k) submission requirements.
- Compliance Without Complexity
Meet FDA, ISO, MDR, HIPAA, and GDPR requirements with built-in modules, validated workflows, and audit-ready records.
- Workflow-Driven QMS Modules
Automate CAPAs, deviations, complaints, change controls, training, and more. Prebuilt flows keep you compliant—custom flows keep you in control.
- All-in-One Platform
Everything you need: Document control, electronic signatures, risk management, traceability, project and task tracking, custom forms, and audit trails.
- Build What You Need
Create unlimited custom modules, workflows, and topic-specific logs. Model any quality or operational process your team requires.
- Collaborate Without Switching Tools
Integrated messaging, task management, and project tracking keep conversations connected to actions.
- CAPA Management
- Deviation Management
- Nonconformity Management
- Change Management
- Customer Complaint / Feedback Management
- Training Management
- Supplier Management
- Audit Management
- Risk Management (ISO 14971)
- Hazard Logs
- Document Control with Versioning
- Electronic Signatures (21 CFR Part 11 compliant)
- Traceability Matrix
- Quality Manual Builder (with 80 Word Templates & 85 SOPs)
- Reporting Module
- Built-in Validation Package
- Custom Module Builder – Create unlimited modules and topic-specific logs
- Form Builder – Design your own custom input forms
- Workflow Builder – Automate approvals, escalations, and reviews
- Prebuilt workflows for change control, NCs, complaints, training, and more
- Project Management Module
- Task/Issue/Event Management Module
- Conversation Module – Threaded, context-based internal communication
- Wrapper Desktop App – Real-time document editing and cloud sync
- Quick Access Dashboard for forms, tasks, and processes
- Secure Hosting with Daily Backup
- Windows/Mac/Linux Compatibility
- Role-Based Permissions
- Maintenance & Technical Support
- New Releases with Validated Updates
- API Integration with Jira
- Complimentary Onboarding & Training
- Setup Support
- Built-in Validation Documentation
- Fast Time-to-Compliance
- FDA 21 CFR Part 820 – Quality System Regulation
- FDA 21 CFR Part 11 – Electronic Records & Signatures
- FDA 510(k) – Submission-ready structure and traceability
- ISO 13485:2016 – Medical Devices QMS
- ISO 9001:2015 – General Quality Management
- ISO 14971:2019 – Risk Management for Medical Devices
- IVDR
- SaMD (Software as a Medical Device) and SaaS in regulated environments
- EU MDR / CE Marking
- UK MDR / UKCA
- GDPR – EU General Data Protection Regulation
- HIPAA – US Health Information Privacy and Security
Whether you're submitting a 510(k), preparing for ISO audits, or maintaining compliance for your SaMD across the US and EU, qmsWrapper is designed to support your journey.
- MedTech startups – Preparing for their first audit or FDA submission
- Medical device companies – Managing FDA 510(k), De Novo, CE, and UKCA submissions
- Diagnostics & biotech firms – Ensuring traceability, training, and risk management
- Contract manufacturers – Maintaining quality across multiple client projects
- Early-stage teams – Building a compliant QMS from day one
- ISO-certified companies – Maintaining ISO 13485, ISO 9001 with less overhead
- SaaS/Software as a Medical Device developers – Navigating IVDR and FDA regulations
- Quality teams – Who want to automate, not micromanage
From your first audit to your tenth FDA or notified body submission, qmsWrapper brings control, clarity, and confidence to your compliance process.
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.
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Next qmsWrapper gives you everything you need—without the clutter. Unlike most bulky eQMS platforms, it’s lightweight, fast, and incredibly flexible.
With a clean, intuitive interface and modern user experience, your team actually wants to use it.
Whether you’re launching your first device, submitting a 510(k), or scaling globally, qmsWrapper simplifies compliance so you can move faster with confidence.
