Medical device QMS
software, connected
to design control
Your audit evidence builds itself.
One AI-powered eQMS for documents, CAPA,
complaints, training and suppliers.
“Orcanos served as our ‘single source of truth,’
seamlessly bridging R&D, quality, and regulatory teams.”
to your SOPs
Trusted by 100+ medical device companies worldwide
of auditing in a week and a half, run entirely inside Orcanos
"In a week and a half, I had four days of auditing. No back room. No binders. No scrambling. Everything was handled directly inside Orcanos."
What is medical device
QMS software?
Medical device QMS software, often called an eQMS, is the system a device company uses to control its documents, CAPAs, complaints, training, suppliers and audits, and to prove to FDA, notified bodies and MDSAP auditors that its products
are consistently safe and meet ISO 13485.
Most eQMS platforms stop at the quality record. Design controls, requirements and risk files live in a separate ALM tool, so the links between them are kept by hand. Orcanos puts the QMS and design controls on one data model, so a complaint, a CAPA, a requirement and
a test can be traced in one place.
suppliers, audits, management review, PMS
EU MDR, MDSAP, ISO 14971
and disconnected QMS and ALM tools
Tired of dreading audit week?
Your team isn't the problem. Your evidence lives in too many places.
The pre‑audit fire drill
Two weeks of exporting,
screenshotting and cross-
referencing to prove one
CAPA closed properly. Your
best people stop doing quality
work and start doing
archaeology.
The training chase
An SOP changes. Someone
works out by hand who needs
retraining, emails them, follows
up, then reconciles
a spreadsheet against an
HR system never built for this.
The silent expiry
A supplier's ISO 13485 certificate lapsed four months ago. Nobody noticed, because the reminder sat in the calendar of someone who has since left.
The broken chain
A complaint became an NCR,
the NCR a CAPA, the CAPA
a design change. Now prove
it when every step lives in
a different tool with a different
ID scheme.
Stop being the human glue
between your systems.
Every one of those problems is the same problem. Quality records and engineering records
live in different systems, so every link between them has to be kept up, remembered
and rebuilt by a person. In Orcanos, the QMS and design controls share one data model.
Quality and R&D work from a single source of truth, and the links are stored as data.
They can test you.
Watch you. Inspect you.
You're ready.
Follow one complaint from intake to audit. This is the walk an auditor asks for. In Orcanos, each step is linked to the one before it, including the step into design control.
Logged, assessed for reportability, and
the vigilance clock starts.
Disposition set, lot family flagged
for trending.
Root cause confirmed with 5
Why and linked to the FMEA risk.
same CAPA
The affected requirement
and test are flagged on
the design side.
The NCR feeds the scorecard and a supplier corrective action opens.
Reviewed and approved with Part
11 signatures. Old version withdrawn.
Assigned by role on release
and tracked as it happens.
Open CMP‑115 and follow every linked record, in order.
What does Orcanos QMS include?
Seven quality modules, plus risk and design control on the same record.
Document control software
for medical device teams
Every controlled document in one system, with review, approval and training built into each release.
CAPA and nonconformance
management software
One closed loop from a nonconformance to a verified fix, with the root cause linked to your risk file.
Complaint handling software
with reportability built in
Complaints are assessed, escalated and reported from the same record that holds the CAPA and the design history.
Training management software
for ISO 13485 competency
The right people trained on the right revision, and proof of it on any day.
Supplier management
and qualification software
Qualification, certificates and performance for every supplier, tracked by the system.
Audit management software
for internal, supplier and MDSAP audits
Plan, run and close audits in the system your auditor will review.
Management review
and post‑market surveillance
Review inputs and PMS evidence assembled from live data, not collected from five people.
ISO 14971 risk management
linked to quality events
Risk files that update when a complaint, CAPA or design change touches them.
Design control and DHF on
the same record as your QMS
The R&D side of Orcanos: design inputs, outputs, verification and validation, connected to every quality event.
Stop digging. Just ask.
One question, answered from Quality and R&D together.
Most QMS assistants can only read the quality record.
Ask Paul works on the one data model Orcanos shares with design
controls, so it can answer questions that cross from a CAPA to
a requirement to a risk, with a link to every source record.
or requirements and get the answer
with direct links to the artifact.
and compliance overviews from
live records.
Compliance, connected. Confidence, constant.
Get your evenings back before audit week,
and be the one with the answer when the CEO asks if you're ready.
Live in weeks
Average go‑live is 24 days,
against the three to six months
legacy platforms usually quote.
Your SOPs stay yours
A drag‑and‑drop workflow
builder and eForms that match
the procedures you already
had approved.
QMS and ALM together
No integration to maintain
between Quality and design
control, and no second
vendor for R&D.
Lower compliance costs
Less time rebuilding
evidence, reconciling tools
and preparing for audits.
One QMS from first prototype
to global portfolio
Some platforms were built for your first audit. Orcanos was built for every audit after that.
Reach CE marking and
FDA clearance without building
a compliance department
"We obtained both CE certification
and FDA clearance with Orcanos."
Add products, markets
and post-market
work without
re-platforming
"As a startup, their attention helped
us transition smoothly into the digital world."
Put Quality and R&D
on one record across sites
and product lines
Trusted by teams at GE HealthCare,
Medtronic and PerkinElmer.
How Orcanos QMS compares
Most teams come to us from spreadsheets and SharePoint,
a legacy QMS, or a QMS and an ALM tool stitched together.
in one record
on document release
Connected to the tools
engineering already uses
Software teams keep working in their own tools. Orcanos syncs their work into the design and quality record, so traceability holds for software-driven devices and SaMD.
Built for the regulations
you're audited against
Frequently asked questions about
medical device QMS software
What is the best QMS software for medical devices?
The best medical device QMS is one built for ISO 13485 and FDA QMSR, validated for 21 CFR Part 11, and able to trace quality events back to design controls and risk. If your R&D team works in a separate tool, look for a platform that keeps QMS and design control on one data model, as Orcanos does, so traceability doesn't depend on manual syncing.
What is medical device QMS software?
Medical device QMS software, often called an eQMS, is the system a device company uses to control documents, CAPAs, complaints, training, suppliers and audits, and to prove to regulators that its products consistently meet ISO 13485 and applicable regulations.
What is the difference between a QMS and an eQMS?
A QMS is the set of processes and records a company uses to manage quality. An eQMS runs that QMS in software instead of paper, shared drives and spreadsheets, with controlled records, approvals, electronic signatures and audit trails in one system.
What is the difference between a QMS and ALM, and why connect them?
A QMS manages quality processes such as CAPA, complaints and training. ALM manages product development: requirements, design controls, risk and testing. When they are separate, every link between a quality event and a design decision is kept by hand. Orcanos runs both on one data model, so those links are maintained automatically.
Do I need a QMS before my product launches?
Yes. ISO 13485 and FDA's QMSR require design controls during development, and notified bodies audit your QMS before CE marking. Starting with an eQMS early means your design history file builds as you work instead of being reconstructed before submission.
Why can't we keep running our QMS in Excel and SharePoint?
Spreadsheets and shared drives don't enforce approvals, electronic signatures or audit trails, and they can't link a complaint to its CAPA, document change and training. Teams end up spending around two weeks of senior QA time rebuilding that evidence before every audit.
Why choose a medical device-specific QMS over a general one?
General QMS tools serve many industries and leave device-specific requirements such as design controls, ISO 14971 risk management, vigilance reporting and MDSAP to configuration or add‑ons. A medical device QMS includes them from the start.
How is Orcanos different from other medical device QMS platforms?
Orcanos keeps the QMS and design controls (ALM) on one data model, so a complaint, CAPA, requirement, risk and test are traceable in one record. It goes live in 24 days on average and is configured around your existing SOPs with no‑code workflows.
Does Orcanos support ISO 13485, EU MDR and MDSAP?
Yes. Orcanos QMS covers the ISO 13485 quality system processes, EU MDR post‑market surveillance and vigilance records, and MDSAP audit programs with checklists mapped to MDSAP chapters.
Is Orcanos compliant with 21 CFR Part 11?
Orcanos provides 21 CFR Part 11 electronic signatures with unique user authentication, version history and full audit trails for controlled records.
What is FDA's QMSR and does Orcanos support it?
The Quality Management System Regulation took effect on February 2, 2026 and incorporates ISO 13485:2016 into 21 CFR 820. Because Orcanos QMS is structured around ISO 13485 processes, it supports the QMSR framework.
How does CAPA management work in Orcanos?
A complaint, NCR or audit finding opens a CAPA with an owner and due date. Root cause analysis, corrective actions, document revisions and training all link to it, and an effectiveness check must pass before the CAPA can close.
What is Ask Paul?
Ask Paul is the AI compliance assistant built into Orcanos. It answers questions in plain language across your quality and design records, with links to each source record, and generates audit summaries, detects risk gaps and monitors regulatory changes.
Does Orcanos integrate with Jira, GitHub or Azure DevOps?
Yes. Engineering teams can keep working in Jira, GitHub or Azure DevOps while their work stays traced in the Orcanos design and quality record.
Is Orcanos suitable for early-stage startups?
Yes. ZygoFix obtained both CE certification and FDA clearance with Orcanos, and IceCure started on it as a startup. The same system supports post‑market and multi-product work as you grow.
How long does it take to implement Orcanos QMS?
The average go‑live time is 24 days, compared with the three to six months many legacy QMS platforms quote.
What if our workflow doesn't match yours?
It doesn't have to. Workflows, form fields and access rules are configured in a drag‑and‑drop builder around the SOPs you already have approved, with no developers needed.
Can we migrate from our current QMS or from paper?
Yes, you can seamlessly migrate to Orcanos whether you are transitioning from a legacy electronic QMS or moving away from paper-based binders. Orcanos provides dedicated migration tools and smart import interfaces to bulk-transfer your data to Orcanos while preserving the correct record structure.
Who handles software validation?
Orcanos provides an off-the-shelf, full Validation Package that ensures the system meets all functional and regulatory requirements, including compliance with 21 CFR Part 11.
How do I justify the cost of an eQMS to leadership?
Start with what the current setup costs: about two weeks of senior QA time before every audit, repeated data gathering for each management review, and the risk of findings from broken traceability. Orcanos customers see an average 30% reduction in compliance costs and go live in 24 days.
Walk into your next audit
calm.
Bring us your worst quality process. Tell us how it runs today: the tools, the handoffs, the step that eats your week. That's the 30-minute discovery call. If Orcanos is a fit, the second call is a live demo built on that exact process.