QMS software for medical device companies. Audit-ready in 24 days.
Stop losing weeks to spreadsheets, binders and audit prep. Orcanos puts document control, CAPA, complaints, audits, suppliers and training in one validated system built only for MedTech.
- ISO 13485, EU MDR and FDA 21 CFR Part 11 built in, not bolted on
- Live in 24 days. Legacy QMS vendors take 3 to 6 months
- Change any workflow yourself, no code, no consultants
100+ medical device companies · 30% lower compliance costs · No credit card
See Orcanos on your own process
Not a generic slideshow. Bring one real pain: a CAPA, an audit, a document cycle.
- Watch your SOPs mapped into Orcanos live
- Get a 24-day go-live plan for your team
- Leave with pricing for your company size
“Four days of auditing. No back room. No binders.”Hein Smit Sibinga, VP Quality, Covaris
Trusted by 100+ medical device companies worldwide
Every quality process. One system.
ISO 13485 and EU MDR compliance without the legacy overhead. Pre-configured best-practice templates, adaptive workflows you change with no code.
Document control
Versioning, approvals and 21 CFR Part 11 electronic signatures.
CAPA management
Root cause to closure, traceable to the triggering event.
Complaints
Intake, investigation and reporting in one closed loop with CAPA.
Audit management
Plan internal and supplier audits, track findings and evidence.
Supplier qualification
Approved supplier list, evaluations and re-qualification reminders.
Training management
Assignments tied to job roles, auto-triggered on document changes.
Risk management
ISO 14971 risk files linked to design changes and complaints.
Ask Paul, AI assistant
Ask about your QMS in plain language, get audit summaries in minutes.
Sound familiar?
Most teams come to Orcanos from a legacy QMS, or from Excel and SharePoint. Here is what changes.
The Siloed Reality
- Quality records live in PDFs and spreadsheets, versioned by email and outdated by Monday.
- Every design change triggers a manual documentation cascade across 4 tools.
- Audit prep means back-room panic, binders and scrambling for evidence.
- Complaints, CAPAs and risk files tracked separately, reconciled by hand.
- 3 to 6 months to go live on a new QMS platform.
One System. Zero Gaps.
- Live quality records with full audit trail and validated e-signatures.
- Changes propagate automatically through risk, training and document control.
- Audit-ready on any day, any time. No back room. No binders.
- Complaints, CAPAs and risks connected in one closed loop.
- Go live in 24 days, not 6 months.
Trusted by teams who can't afford compliance gaps.
From first CE mark to global MedTech leaders, here is what quality and regulatory leaders actually say.
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.
“We passed our recent audit completely paperless.”
The attention given to the customer on any issues that arise is very impressive.
“We obtained CE certification and FDA clearance with Orcanos.”
We were impressed by Orcanos' attention and expertise in the medical device industry. It was the right choice for ZygoFix.
“The built-in templates correspond to the FDA guidance and are a huge time saver.”
Orcanos is tailored to the medical device industry. Traceability is key to a successful audit.
“Our single source of truth for FDA 510(k) clearance and CE marking.”
Their eQMS gave us the total confidence and data integrity needed to clear these major regulatory hurdles efficiently.
“Quick onboarding, thanks to the simple and intuitive operation.”
We were able to easily adapt our workflows and documents. A very good alternative to outdated procedures.
Stay audit-ready without the scramble.
Your job is to keep the company compliant, not to spend weeks preparing for every audit. Orcanos keeps documents, CAPAs, training records and supplier data always current, always traceable, always ready for review.
- CAPA and complaint workflows with full traceability from event to closure.
- Document control built for 21 CFR Part 11 and ISO 13485, with validated e-signatures.
- Training compliance tracked automatically, with assignments tied to job roles.
- Audit prep in minutes, not days, with on-demand DHF and quality record access.
How does Orcanos compare?
Most teams switch from a legacy QMS or from Excel and SharePoint. Here is how the switch looks.
| Capability | Orcanos | Legacy QMS | Excel / SharePoint |
|---|---|---|---|
| Built only for medical devices | Yes | Partial | No |
| Go live in under 24 days | Yes | 3 to 6 months | DIY |
| 21 CFR Part 11 e-signatures and audit trail | Yes | Yes | No |
| Adaptive compliance: your process, your rules | Yes | No | No |
| AI-powered compliance assistant | Yes | No | No |
| QMS connected to design controls and risk | Yes | No | No |
From demo to audit-ready in less than 24 days.
The fastest medical device QMS implementation on the market.
Book a demo
See Orcanos live with your actual use case, not a generic walk-through. 30 minutes, no sales pressure.
Scoped onboarding
Our MedTech experts map your existing SOPs and data into Orcanos. You keep your process, we adapt to it.
Go live in 24 days
Team trained, data migrated, workflows validated. Most customers go live in under two weeks.
Questions teams ask before choosing Orcanos
Does Orcanos support ISO 13485 and EU MDR?
Yes, both are built in at the core. Orcanos includes pre-configured workflows for document control, CAPA, audits, supplier management and training aligned with ISO 13485, plus technical documentation and post-market surveillance support for EU MDR 2017/745.
Is Orcanos FDA 21 CFR Part 11 compliant?
Yes. Document control includes validated electronic signatures and a complete, real-time audit trail for every record, approval and change, so quality records are inspection-ready at all times.
How long does implementation take?
Most Orcanos customers go live within 24 days. Best-practice templates and a no-code configuration environment replace the 3-month onboarding cycles typical of legacy QMS vendors.
Can we customize workflows without coding?
Yes. Quality managers create and modify workflows, forms and field types with the no-code builder. Orcanos adapts to your process, not the other way around.
Is Orcanos suitable for early-stage startups?
Yes. Orcanos scales from startups seeking a first CE mark or FDA clearance to established manufacturers managing complex portfolios. Flexible pricing and rapid onboarding make it accessible at any size.
Can we add ALM and design controls later?
Yes. Orcanos QMS and ALM share one data model, so you can start with the QMS and add requirements, risk and test management when you need them, without integrations.
Ready to go audit-ready in 24 days?
Join 100+ medical device companies that chose Orcanos to unify quality, documents and risk, without the implementation nightmare.
Get a free demoNo credit card required · Setup in minutes · Dedicated onboarding included