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.
Everything Quality and R&D teams need.
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.
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.
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.
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.”
The Siloed Reality
One System. Two Teams. Zero Gaps.
In a week and a half I had four days of auditing… everything was handled directly inside Orcanos. No scrambling.
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.
One Platform for QA and R&D
Requirements linked to hazards to mitigations - automatically. Design changes trigger risk re-assessment in real time.
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.
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.
Learn About Ask Paul →
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
Scrambling to meet FDA, MDR, GMP, MDSAP, 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.
Accelerated Time-to-Market
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.
Deep Requirement Traceability
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.
Quality or R&D - Orcanos speaks your language.
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.
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 into the digital world.
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.
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.
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
Everything you need to know about our platform, compliance coverage, and getting started.
Can we customize workflows without coding?
What is Ask Paul?
How does Orcanos help during FDA or notified body audits?
Is Orcanos suitable for early-stage startups?
What's the difference between the QMS and ALM modules?
Does Orcanos support ISO 13485 and EU MDR?
How long does implementation take?
What is Orcanos?
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