Scattered records
Documents, quality events, risks and design evidence live in different places, making the current state hard to see.
Trusted by medical-device teams
The problem
Your QMS should support your team, not become a second job.
Most QMS platforms in medtech were built for companies with a full-time quality department — and then sold to companies that don't have one.
Manual traceability
Teams rely on spreadsheets and memory to work out what a change affects and which records must be updated.
Audit prep as a project
Missing approvals, outdated records and incomplete links are discovered too late to fix calmly.
One platform · three levels
Buy the level you need now. Add the rest when you need it.
Most QMS platforms sell you the whole system on day one. qmsWrapper sells you the level your regulatory obligations actually require — and nothing you are not yet required to run.
Start
Foundation
Move from paper, Word templates and shared folders to controlled quality processes.
- eForms, taskforms and records
- Documents, approvals & e-signatures
- Training and QMS Manual
- Storage, tasks and controlled logs
- AI form assistance and knowledge search
From €3,499/year
Connect
Lifecycle
Connect quality events, decisions, risks and product-lifecycle workflows.
- CAPA, Change and Nonconformity
- Deviation and Feedback
- Risk and Hazard management
- Supplier and event workflows
Priced on company sizeSee pricing
Oversee
Vigilance
Add evidence-ready post-market and regulatory oversight.
- Technical File & traceability visibility
- PMS and vigilance
- Audit and regulatory evidence
- Readiness and governance
Priced on scopeSee pricing
No per-seat licences. Everyone who touches quality gets access — pricing is based on company size, not user count.
Not sure which level fits? Tell us what you're using now
AI in the QMS
Four things it actually does.
Each feature is tagged with the level it belongs to
Change Impact Analysis Level 2 · Lifecycle
Know what a change touches before you make it.
Ask what a supplier swap, design change or requirement edit affects. Get the documents, risks, training records and Technical File sections back as a list — not a hunch.
Automatic Traceability Level 2 · Lifecycle
The matrix maintains itself.
Links between requirements, design outputs, risks and verification stay current as things change. Nobody rebuilds the matrix the week before an audit.
Smart Form Assistant Level 1 · Foundation
Forms arrive already filled in.
CAPA, complaint and deviation forms pre-populate from what the system already knows about the product, the lot and the history. You review rather than retype.
QMS Knowledge Search Level 1 · Foundation
Ask your QMS a question in plain language.
“Which SOPs reference our EO sterilisation supplier?” Answered from your own controlled documents, with the source records cited.
How the AI is kept under control.
qmsWrapper can help you complete forms, surface relevant records, propose connections, summarise information and identify gaps. It does not do the work for you: regulated decisions and approvals remain with authorised users, and the audit trail treats AI like any other change, because an auditor will.
Reviewable outputs
Users can review and edit AI-assisted work.
Human approval
Final decisions remain with authorised users.
Controlled access
Permissions are appropriate to each level.
Audit trail
Actions and decisions remain documented.
Controlled AI and level-based MCP access for approved AI agents.
Level-appropriate AI agents can search, draft, summarise, propose links and prepare evidence. They do not approve CAPA closure, reportability, significant change decisions, risk acceptability, Technical File release or regulated submissions.
What auditors see
Every record carries its own history.
- Who approved it, when, and against which version
- 21 CFR Part 11 compliant electronic signatures
- Complete, tamper-evident audit trails
- A traceability matrix that was current the moment it was asked for
500+ startups have been audited on qmsWrapper and hold FDA and CE compliance.
Audit trail · SOP-014 rev 6
14 Aug
09:12 M. Bisnaire approved revision 6
✓ e-signature · 21 CFR Part 11
09:12 M. Bisnaire approved revision 6
✓ e-signature · 21 CFR Part 11
13 Aug
16:40 AI · Change Impact proposed 4 linked records for review
✓ reviewed by A. Kovač · reversible
16:40 AI · Change Impact proposed 4 linked records for review
✓ reviewed by A. Kovač · reversible
13 Aug
16:38 A. Kovač edited §5.2 Supplier requalification interval
16:38 A. Kovač edited §5.2 Supplier requalification interval
02 Jun
11:05 System re-assigned training TRN-021 to 6 users
11:05 System re-assigned training TRN-021 to 6 users
Supplier qualification
Everything your procurement team will ask for.
You will be supplier-auditing us. Here is what we hand over, before you have to ask.
Validation pack
Pre-validated SaaS. IQ/OQ evidence, validation summary and release documentation supplied on request.
SOC 2 and ISO 27001 in progress
Both certifications are currently in progress. Our existing security controls, policies and hosting documentation are available under NDA in the meantime.
Hosting & residency
EU and US hosting regions. You choose where your records live, and we tell you where the backups are.
Backup & recovery
Documented backup schedule, RPO/RTO targets and a data-export path if you ever leave.
Customer reviews
“qmsWrapper is comprehensive yet lightweight, easy to navigate with a modern interface.”
“Every time we get a data point, the app makes it easy to capture it and assign it to someone so it can be dealt with properly.”
“Implementing the design controls and risk management activities is intuitive.”
Compare
See how qmsWrapper compares.
We publish the comparison ourselves, including where the other platform wins. If we won every row, you wouldn't believe any of them.
Head to head
vs Greenlight Guru
16 dimensions compared: AI access by tier, pricing transparency, licensing model, setup effort and regulatory coverage.
Read the comparison →
Head to headvs Qualio
Where each platform wins, what switching involves, and a like-for-like look at which AI features sit behind which tier.
Read the comparison →
Buyer's guideHow to evaluate any eQMS
The questions worth asking every vendor — including the ones we'd rather you didn't ask us.
Open the guide →
Before you book
Questions we get asked first.
Is qmsWrapper an AI QMS?
Yes. qmsWrapper is an AI-enabled eQMS. AI prepares forms, maintains traceability, analyses change impact and answers questions from your controlled documents. Authorised users still review and approve every regulated decision, and every AI-assisted action is logged, attributed and reversible in the audit trail.
How much does qmsWrapper cost?
Foundation starts at €3,499 per year. Lifecycle is priced on company size and Vigilance on scope. See pricing
Do you charge per user?
No. qmsWrapper is not licensed per seat — everyone in your organisation who touches quality can have access. Pricing is based on company size rather than user count, so adding a reviewer or an auditor never changes your invoice.
Who is qmsWrapper for?
Medical device, SaMD and IVD teams — from startups seeking first certification to growing manufacturers maintaining FDA and CE compliance across multiple products.
Start where the need is greatest.
Whether you're transitioning from paper or upgrading an existing system, keep what you build and add the next level when you need it. We'll walk you through how your current processes, regulatory priorities and plans for growth fit together.
“We're changing the sterilisation supplier for Device A. What does that touch?”
4 affected records found
- SOP-014Supplier QualificationRevise
- RMF-002Risk Management File — Device ARevise
- TF-A §4.3Technical File — SterilisationReview
- TRN-021Training — Incoming InspectionRe-assign
AI proposes. An authorised user approves. Every action stays in the audit trail.
Regulatory coverage
qmsWrapper helps medical device, SaMD, IVD and MedTech teams move from paper-based QMS records to connected regulatory evidence, with AI assistance and human approval at each level. Start where the need is greatest, keep what you build, and add the next level when ready.
