Orcanos - eQMS & ALM Software for Medical Devices | ISO 13485
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Products ▾ Features ▾ Resources ▾ Company ▾ Customers Pricing
✦
AI-Powered · ISO 13485 · FDA 21 CFR Part 11
Medical Device Compliance,Built for Speed
Orcanos unifies QMS and ALM into one platform - so your R&D and Quality teams move faster, stay audit-ready, and never lose traceability.
✓
FDA Submission Ready
DHF compiled in minutes
98%
Audit Readiness
Design Control Completeness
85%
Training Compliance
94%
ISO 14971 Risk Coverage
62%
Open NCRs
3
Linked Risks
142
⚡
Go Live in 24 Days
No 3-month onboarding
Hero Network Background - Snippet
Trusted by 100+ medical device companies worldwide
24
-day
Average go-live time
30
%
Reduction in compliance costs
100
MedTech companies worldwide
✦
The Platform
Everything Quality and R&D teams need.
One platform.
Three deeply integrated modules that eliminate the data silos killing your compliance efficiency.
Regulated ALM
Bridge the gap between software development and Design Controls. End-to-end traceability from requirement to test, audit-ready by default.
✓
Requirements & Design Controls
✓
Risk Management (ISO 14971)
✓
Test Management & Traceability
✓
Defect Tracking with DHF linkage
✓
GitHub / Jira / Azure DevOps integrations
Next-Gen eQMS
ISO 13485 and EU MDR compliance without the legacy overhead. Go live in 14 days with best-practice templates and adaptive workflows.
✓
Document Control (21 CFR Part 11)
✓
CAPA & Complaint Management
✓
Audit & Supplier Management
✓
Training Management with auto-assignments
Ask Paul - AI Assistant
The first MedTech AI assistant built for compliance, not just chat. Write requirements, spot risk gaps, and prepare audit summaries in minutes.
✓
AI-assisted requirement writing
✓
Automated risk gap detection
✓
Audit summary generation
✓
Regulatory change monitoring
✓
Natural language traceability queries
✦
One Data Layer
The only platform that bridges QMS and ALM at the data layer.
Most companies buy separate tools for Quality and R&D, then spend months trying to make them talk. Orcanos is architected differently: QMS and Engineering Design Control (ALM) share one data model, so every design change is automatically assessed for quality impact and regulatory compliance. No integrations to break. No manual sync. No “different versions of the truth.”
Without Orcanos
The Siloed Reality
✕
R&D lives in Jira or Excel. QA lives in a separate QMS. Neither talks to the other.
✕
Every design change triggers a manual documentation cascade across 4 tools.
✕
DHF and risk files are PDFs - versioned, emailed, and outdated by Monday.
✕
Audit prep = back-room panic, binders, scrambling for evidence.
✕
Post-market surveillance is a manual loop that eats weekends.
✕
3-6 months to go live on a new QMS platform.
With Orcanos
One System. Two Teams. Zero Gaps.
✓
ALM and QMS share a single data model - R&D and Quality always in sync.
✓
Design changes auto-propagate through traceability, risk,
and validation.
✓
Dynamic databases replace PDF graveyards - live risk and DHF, always current.
✓
Audit-ready on any day, any time. No back room. No binders.
✓
Complaints and CAPAs connected in one closed loop. Weekends restored.
✓
Go live in 24 days, not 6 months.
“
In a week and a half I had four days of auditing… everything was handled directly inside Orcanos. No scrambling.
Hein Smit Sibinga, VP of Quality and Regulation · Covaris
✦
Features
Traceability & Adaptive Workflows
Stop managing silos. Orcanos unifies QMS and ALM into a single source of truth, so every design change is automatically reflected in your compliance posture.
✦
Traceability
One Platform for QA and R&D
Stop managing silos. Orcanos unifies QMS and ALM into a single source of truth, so every design change is automatically reflected in your compliance posture - without manual reconciliation.
Requirements linked to hazards to mitigations - automatically. Design changes trigger risk re-assessment in real time.
Requirements linked to hazards to mitigations - automatically
Design changes trigger risk re-assessment in real time
DHF compiled on demand - no last-minute scrambling
Artifact
Status
Linked to
REQ-042
✓ Approved
RISK-12
SRS-007
⏳ In Review
TC-88
RISK-12
✓ Mitigated
CAPA-03
Custom Workflow Builder
Drag-and-drop, no code required
Active
Role-Based Access Control
Per-artifact, per-team permissions
Active
Custom Form Fields
Any field type, any regulation
Active
Intelligent Traceability
Link across any artifact type
Active
✦
Adaptive Compliance
Your Process, Your Rules
Most systems demand you work “their way.” Orcanos adapts to your unique engineering culture - with no-code custom workflows, granular access controls, and field-type flexibility.
Build custom workflows in clicks - no developers needed
Granular access control that mirrors your org structure
Intelligent traceability - link anything to anything, no rigid hierarchy
Templates - design eForms that align with your existing SOP
✦
AI Assistant
Meet Ask Paul, Your AI Compliance Assistant
Stop digging through SOPs and regulatory documents. Ask Paul answers compliance questions in plain language - surfacing the right artifact, risk, or regulation instantly.
Ask anything about your QMS, DHF, risks, or requirements in natural language
Get instant answers with direct links to the source artifact
Generate compliance summaries and audit prep in seconds
Ask Paul Chat - Snippet
✦
Ask Paul - AI AssistantLive
Which requirements are not yet linked to a risk?
I found 3 unlinked requirements in your current DHF:
• REQ-044: User Interface Feedback
• REQ-071: Battery Warning System
• REQ-083: Alarm Escalation
Want me to generate a risk draft for each based on ISO 14971 hazard categories?
Yes, draft risks for REQ-044
Done. I've created RISK-156 linked to REQ-044 with:
• Hazard: Inadequate user feedback during alarm
• Severity: S3 · Probability: P2 · RPN: 6
• Suggested mitigation: Haptic + audio dual-alert
Assign to a team member?
✦
Why Orcanos
The challenge is real. So is the solution.
Every MedTech team faces the same pain points. We've built Orcanos to solve each one - without the legacy overhead.
Continuous Audit Readiness
The challenge
Scrambling to meet FDA, MDR, GMP, MDSAP, and global requirements during surprise audits - because compliance is reactive, not built-in.
The Orcanos way
Compliance is core architecture, not a layer on top. Always audit-ready, automatically.
Accelerated Time-to-Market
The challenge
Bottlenecks in documentation and manual approval workflows that delay product launches and frustrate engineering teams.
The Orcanos way
Automated compliance processes free your teams to focus on innovation, not paperwork.
Deep Requirement Traceability
The challenge
Gaps in your traceability matrix that only surface during regulatory review - leading to costly rework and delays.
The Orcanos way
Every design change automatically assessed for risk impact and regulatory compliance - zero gaps.
✦
Built for Your Role
Quality or R&D - Orcanos speaks your language.
VP Quality
VP R&D
Regulatory Affairs
✦
VP Quality
Stay audit-ready without the scramble.
Your job is to keep the company compliant, not to spend weeks preparing for every audit. Orcanos gives Quality teams a single system where documents, CAPAs, training records, and supplier data are always current, always traceable, and 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 is tracked automatically, with assignments tied to job roles.
Audit prep in minutes, not days, with on-demand DHF and quality record access.
✦
Customer Stories
Trusted by teams who can't afford compliance gaps.
From fast-growing startups to global MedTech leaders - hear what quality and R&D 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.
Hein Smit Sibinga
VP of Quality and Regulation
We obtained both CE certification and FDA clearance with Orcanos. The attention and expertise in the medical device industry made this the right choice for ZygoFix.
Ofer Levy
CEO
Orcanos provided the optimal solution for documenting and distributing requirements. As a startup, their attention helped us transition smoothly into the digital world.
Naum Muchnik
VP R&D
✦
Why Orcanos
How does Orcanos compare?
Most teams come to us from one of three places: Excel + SharePoint, a legacy QMS, or separate QMS + ALM tools. Here's how the switch looks.
| Capability | Orcanos | Separate QMS & ALM | Legacy QMS | Excel / SharePoint |
|---|---|---|---|---|
| QMS & ALM unified data model | ✓Yes | –No | –No | –No |
| Go live in under 24 days | ✓Yes | –No | 3–6 mo | DIY |
| AI-powered compliance assistant | ✓Yes | Some | –No | –No |
| Adaptive Compliance: Your Process, Your Rules | ✓Yes | –No | –No | –No |
| ISO 13485 | IEC 62304 | ISO 14971 | ✓Yes | ✓Yes | ✓Yes | –No |
How Orcanos compares with separate QMS & ALM tools, a legacy QMS, and Excel / SharePoint
Swipe to see all columns →
✦
Getting Started
From demo to audit-ready in less than 24 days.
We’ve removed every excuse to delay.
The fastest medical device QMS implementation on the market.
1
Book a Demo
See Orcanos live with your actual use case - not a generic walk-through. 30 minutes. No sales pressure.
2
Scoped Onboarding
Our MedTech experts map your existing SOPs and data into Orcanos. You keep your process - we adapt to it.
3
Go live in 24 days
Team trained, data migrated, workflows validated. Most customers go live in under two weeks.
✦
Our Badges
✦
FAQ
Questions teams ask before choosing Orcanos
Everything you need to know about our platform, compliance coverage, and getting started.
Can we customize workflows without coding?
Absolutely. Orcanos's no-code workflow builder lets quality managers create and modify workflows, forms, and field types without involving developers. Your QMS adapts to your process - not the other way around.
What is Ask Paul?
Ask Paul is Orcanos's AI-powered compliance assistant. Teams can ask questions about their DHF, risk records, and regulatory obligations in plain language. Ask Paul surfaces the right artifact, generates ISO 14971 risk drafts, and helps teams prepare for audits - all from within the platform.
How does Orcanos help during FDA or notified body audits?
Orcanos maintains a complete, real-time audit trail for every record, approval, and change. Document control includes 21 CFR Part 11-compliant electronic signatures. Your Design History File, risk management files, and quality records are instantly accessible - so your team is always inspection-ready, not just at audit time.
Is Orcanos suitable for early-stage startups?
Yes. Orcanos scales from early-stage startups seeking their first CE mark or FDA clearance all the way to established manufacturers managing complex portfolios. Flexible pricing and rapid onboarding make it accessible at any company size.
What's the difference between the QMS and ALM modules?
The QMS covers quality processes - document control, CAPA, audits, nonconformances, supplier management, and training. The ALM covers the development lifecycle - requirements, design control, risk traceability, test management, and DHF compilation. Together they form one unified source of truth bridging R&D and Quality.
Does Orcanos support ISO 13485 and EU MDR?
Yes - both are built in at the core. The platform includes pre-configured workflows, document control, CAPA, audit management, and training automation aligned with ISO 13485, plus technical documentation and post-market surveillance support for EU MDR 2017/745.
How long does implementation take?
Most Orcanos customers go live within 24 days. Unlike legacy providers that require 3-month onboarding cycles, Orcanos provides out-of-the-box QMS best practices and a no-code configuration environment - so you're audit-ready from the start.
What is Orcanos?
Orcanos is a cloud-based QMS and ALM platform built specifically for medical device companies. It unifies quality, R&D, and risk management in a single validated environment - supporting ISO 13485, EU MDR, FDA 21 CFR Part 11, and ISO 14971 compliance.
Ready to go audit-readyin 24 days?
Join 100+ medical device companies that chose Orcanos to unify quality, development, and risk — without the implementation nightmare.
No credit card required · Setup in minutes · Dedicated onboarding included
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