Skip to content

The Unified, AI-Powered QMS for MedTech Teams

End-to-end compliance, smarter workflows, and connected traceability — all in one platform designed for ISO 13485, FDA 21 CFR, and EU MDR.

qmsWrapper connects your design and quality systems through interlocking QES (Quality Event System) and DHS (Design History System) — making every requirement, change, and risk traceable by default.
AI helps you fill forms, link records, and flag gaps — so you spend less time managing compliance, and more time building better devices.

Compliance-ready software

Wetling BreatheSuite Miridia Maestro logistics Liberty Vision KeborMed Grownetics Glyciome Spars Getica Digital MedLab AbilityMade 4D Path Otn implants Kaefer Inova medical iAssay Vocare United Vein Titus medical Molbiol Smellcells Simple HealthKit Saccade Realize Medical Pharmtex Meditec Peek Vision Globe biomedical Fujifilm Fovia Cosiam Cheelcare Calon-cardio AlBayader

Trusted by more than 500+ MedTech teams

⭐⭐⭐⭐⭐

Does your current QMS slow you down instead of helping you scale?

qmsWrapper logo

Audit-ready shouldn’t mean audit-anxious.

Don’t scramble days before. Learn how to be ready every day.


Video Transcript: Audit Readiness for Medical Devices
“Every audit week feels like déjà vu — searching for one more signature, one more policy, one more document you swear was updated. qmsWrapper gives you instant visibility into what’s missing, what’s late, and what’s unresolved — in real time. Unlike other systems, qmsWrapper builds audit readiness into your daily workflow — so the next audit is just another Tuesday.”

Three days before audit, you discover outdated SOPs and missing links? That’s not readiness — that’s roulette.

Stop audit panic with qmsWrapper’s connected QMS. Our medical device quality management system builds audit readiness into your daily workflow with real-time visibility into missing documents and approvals for ISO 13485 compliance.

qmsWrapper logo

If it’s not traceable — it’s not defensible.

Your DHF shouldn’t be a puzzle. Discover how qmsWrapper links it all together.

Disconnected logs, fragmented test records, and design updates no one linked back?
If your TM isn’t traceable, your DHF isn’t defensible.

Eliminate DHF traceability gaps with qmsWrapper’s living ecosystem. Our connected system maintains automatic links between design, risks, and quality events, ensuring your design history file is always defensible and audit-ready.


Video Transcript: DHF Traceability Solutions
“When your design lives in one folder, your CAPAs in another, and no one’s quite sure what links to what — you’ve got traceability gaps hiding in plain sight. qmsWrapper creates a live, connected ecosystem between your events, risks, and design. It’s not just linked — it’s living traceability, updated automatically as work happens.”
qmsWrapper logo

Too many CAPAs, too little action?

Learn how smart workflows reduce over-escalation — and save your team’s sanity.


Video Transcript: Smart CAPA Management
“Your team logs a simple deviation — and somehow, you’re stuck managing another full CAPA. Again. When everything becomes critical, nothing gets resolved. qmsWrapper helps filter the noise — using smart classification workflows that escalate only what’s necessary. Because our QMS thinks like you do — it knows the difference between a real issue and routine noise.”

Does every small deviation turn into a full-blown CAPA? Maybe your QMS needs to know what actually matters.

Reduce CAPA overload with qmsWrapper’s smart classification. Our AI-powered workflows automatically triage events based on impact, escalating only what truly matters while turning minor deviations into simple actions.

qmsWrapper logo

Version control should mean… control.

When you can’t trust your files, your auditor won’t either. See how to fix that.

Version mix-ups, missing approvals, outdated SOPs — and no clear answer on what’s current?
When you can’t trust your documentation, you can’t trust your compliance.

End version chaos with qmsWrapper’s complete document lifecycle tracking. Every document tells its full story—from creation to approval to retirement—with timestamps, approvals, and change reasons always traceable.


Video Transcript: Document Control & Version Management
“You open a document, but… is it the right version? Has it even been approved? Who made the last change, and why is your auditor asking questions you can’t answer? qmsWrapper keeps your entire document lifecycle traceable — from creation to approval to retirement. Because in qmsWrapper, every document tells its own story — and you always know the ending.”
qmsWrapper logo

Risk isn’t a document — it’s a mindset.

Bring risk thinking to life — and back into your quality flow.


Video Transcript: Active Risk Management
“You documented the risks. But did anyone revisit them after the last audit? Or after that failed test? qmsWrapper keeps your risks connected to real events and design changes — not buried in a static file. Because our system treats risk like a living signal — one that evolves as your product does.”

Risks logged but never re-evaluated?
Then your risk management is a file — not a mindset.

Transform risk archiving into active risk management. qmsWrapper keeps risks connected to real events and design updates, automatically re-opening them for re-evaluation when tests fail or complaints surface.

qmsWrapper logo

Manual data entry is killing efficiency?

See how AI-powered autofill cuts investigation time—and reduces manual errors.

Copy-pasting data from an NCR into a CAPA is inefficient and error-prone.
Do you spend more time filling out forms than solving the problem?

Eliminate manual data entry with qmsWrapper’s AI assistant. Our system autofills forms, links related records, and suggests root causes—cutting investigation time while reducing human errors.


Video Transcript: AI-Powered QMS Automation
“If your QMS requires you to manually re-type non-conformance data every time you start an investigation, you’re losing critical time. That manual link is also where human errors creep in. qmsWrapper is different. Our AI assistant autofills form data and links related records instantly. It’s not automation for speed — it’s AI for accuracy.”
qmsWrapper logo

System silos are breaking your traceability.

Finally, one platform for QMS, DHF, and Project Management. No more data gaps.


Video Transcript: Unified QMS & Design Platform
“When your design engineers use one platform and your quality team uses another, the crucial link between them is guaranteed to break. qmsWrapper’s interlocking Quality Event and Design systems keep both sides in sync. It’s one ecosystem — not another integration.”

Is your Design History File (DHF) in SharePoint, CAPAs in Excel, and traceability links nowhere at all?
Siloed systems guarantee gaps—and auditors love finding gaps.

Break down tool silos with qmsWrapper’s unified platform. Our interlocking Quality Event System and Design Traceability File keep quality and design teams in sync, eliminating the gaps that auditors love to find.

qmsWrapper logo

Implementation: Weeks, not quarters.

Stop fearing the setup. Get validated and compliant with rapid implementation.

Are you delaying QMS implementation because you fear the cost and complexity?
Enterprise systems are built for massive organizations—not lean MedTech teams.

Skip the costly IT project with qmsWrapper’s rapid deployment. Get a validated, pre-configured QMS live in weeks—not quarters—with built-in compliance for ISO 13485, FDA 21 CFR 820, and MDR.


Video Transcript: Rapid QMS Implementation
“Small teams need to move fast. They don’t have time or budget for complex, 6-month implementations that require external consultants. qmsWrapper is validated, pre-configured, and live in weeks — not quarters. Because quality shouldn’t wait for IT.”

Ready to Make QMS Work for You?

Let us show you how qmsWrapper fits your team.
Choose a path: watch the full video or book your live session right now.

Activate the video!

Fill in your details, go to your inbox (check spam if its not there) and click on the link. It will bring you back to this website.

About

A passionate team behind the scenes

Since 2018, our international team has bridged research, software, and medical innovation. United by a drive to collaborate beyond borders, we’ve turned complex teamwork into clarity.

View more about us

Case Studies

Why wouldn’t you join us?

David Bruinvels

(Data Scientist, PX HealthCare)

“qmsWrapper is an awesome document manager especially for persons looking to transition from paper to electronic record keeping. Excellent user interface, easy to navigate with practice.”

Warren Goldenberg

(COO, KeborMed)

“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 Rosen

(CTO, Osseus Fusion Systems)

“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.”

Alex Hayes

(CTO, Inova Medical)

“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. The custom forms help us to completely transfer our work there instead of having to go back and forth between Word and software.”

Robert Bacsa

(Product Developer, Cardio Phoenix)

“As a start-up, we are new in the MedTech world, and without a customer support and intuitive software we wouldn’t pass the audit. Luckily, we found qmsWrapper just before the pandemic started and moved all our operation to remote, so our work didn’t suffer. Their built-in chat module was a pure lifesaver. We highly recommend it.”

Thomas Trimnal

(CEO, Titus Medical LLC)

“As a startup we were looking for a solution that’s cost-effective to implement, with the functionality we need now, but that can scale up as our needs become more complex. qmsWrapper can grow with us.”

Join for a Free live meetup. It’s on us!

I want a free live demo!

Testimonials

What our clients said

List item 5

List item 5

List item 5

List item 5

List item 5

eSignatures for document approval is something that made us say yes to the software, besides all other features and their price.

Bill M.
Financial internship leader (Capterra review)

List item 5

List item 5

List item 5

List item 5

List item 5

The document management system (DMS) is working fine and for this price level very good, especially as you can download the files easily.

Stephan W.
QA/RA Manager (G2 review)