Medical Device Compliance,
Built for Speed
Orcanos unifies eQMS and ALM into one platform — so your R&D and Quality teams move faster, stay audit-ready, and never lose traceability.
Everything R&D and Quality 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
- Engineering Change Orders
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
Without Orcanos
The Siloed Reality
- R&D lives in Jira or Excel. QA lives in a separate eQMS. 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- DHF and risk files are PDFs — versioned, emailed, and outdated by Monday.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 eQMS 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 14 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, Director Quality & Regulatory · CovarisOne Platform for QA and R&D
Stop managing silos. Orcanos unifies ALM and QMS 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
- 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 | VAL-03 |
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
Meet Ask Paul,
Your AI Compliance Co-Pilot
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 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
• 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?
• Hazard: Inadequate user feedback during alarm
• Severity: S3 · Probability: P2 · RPN: 6
• Suggested mitigation: Haptic + audio dual-alert
Assign to a team member?
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.
Scrambling to meet FDA, MDR, and global requirements during surprise audits — because compliance is reactive, not built-in.
Compliance is core architecture, not a layer on top. Always audit-ready, automatically.
Bottlenecks in documentation and manual approval workflows that delay product launches and frustrate engineering teams.
Automated compliance processes free your teams to focus on innovation, not paperwork.
Gaps in your traceability matrix that only surface during regulatory review — leading to costly rework and delays.
Every design change automatically assessed for risk impact and regulatory compliance — zero gaps.
R&D or Quality —
Orcanos speaks your language.
Ship faster without breaking compliance.
Your team moves fast. Your QMS shouldn't slow you down. Orcanos gives R&D full visibility into how every code commit, design change, and requirement affects your regulatory posture — in real time, without waiting on Quality.
- Automated impact analysis on every design change — know the compliance risk before you merge.
- Live traceability from user needs to verification — DHF always audit-ready.
- R&D and QA finally working from the same data, not emailing PDFs.
- Ask Paul writes IEC 62304-compliant requirements from plain-language descriptions.
Recommended: animated GIF or short video showing requirements → risk → test matrix with live impact highlighting
Audit-ready every day. No more fire drills.
Stop chasing R&D for evidence. Orcanos pulls quality records, design history, and risk data into one live view — so audit prep becomes a five-minute report, not a three-week project.
- Live DHF and risk files — no more PDF graveyards.
- 21 CFR Part 11 e-signatures and full audit trails on every record.
- No-code workflow builder for CAPA, NCR, complaints, and audits.
- Ask Paul flags risk gaps before auditors do.
Recommended: live audit readiness dashboard with CAPA, NCR, and training compliance views
Submissions that hold up under scrutiny.
From technical files to PMS reports, Orcanos structures your data the way notified bodies and the FDA expect it — so submissions move faster and findings stay rare.
- EU MDR technical documentation structured by Annex II.
- FDA 21 CFR Part 11 + ISO 13485 + ISO 14971 alignment out of the box.
- Post-market surveillance loop tied directly to risk and CAPA.
- Ask Paul generates audit summaries and gap reports on demand.
Recommended: structured EU MDR Annex II view with linked design outputs and post-market data
De-risk the company. Free the team.
Compliance failures kill timelines, fundraising, and exits. Orcanos turns quality and regulatory risk into a real-time KPI — so leadership sees gaps before investors, auditors, or notified bodies do.
- One executive dashboard for quality, R&D, and regulatory posture.
- 14-day go-live — predictable cost, predictable timeline.
- Diligence-ready records for fundraising, M&A, and notified body reviews.
- 30% less manual compliance effort — your team focuses on shipping product.
Recommended: top-line quality, audit-readiness, and time-to-market metrics for board reporting
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.
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.
Orcanos provided the optimal solution for documenting and distributing requirements. As a startup, their attention helped us transition smoothly to the digital world.
How does Orcanos compare?
Most teams come to us from one of three places: Excel + SharePoint, a legacy eQMS, or separate ALM + QMS tools. Here's how the switch looks.
| Capability | Orcanos | Separate ALM + QMS | Legacy eQMS | Excel / SharePoint |
|---|---|---|---|---|
| ALM + QMS unified data model | ✓ | — | — | — |
| Go live in under 30 days | ✓ | — | 3-6 mo | DIY |
| AI-powered compliance assistant | ✓ | Some | — | — |
| Auto-impact analysis on design changes | ✓ | — | — | — |
| ISO 13485 + EU MDR + FDA 21 CFR | ✓ | ✓ | ✓ | — |
| No-code adaptive workflows | ✓ | Limited | Limited | — |
| Dedicated MedTech-only platform | ✓ | Some | Some | — |
From demo to audit-ready
in 14 days.
We've removed every excuse to delay. 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 14 Days
Team trained, data migrated, workflows validated. Most customers go live in under two weeks.
Audit-Ready, Always
From day one, your data is structured for ISO 13485, EU MDR, and FDA - so audits are never a surprise.
Questions teams ask
before choosing Orcanos
Everything you need to know about our platform, compliance coverage, and getting started.
Ready to go audit-ready
in 14 days?
Join 500+ 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