Orcanos unifies eQMS and ALM into one platform — so your R&D and Quality teams move faster, stay audit-ready, and never lose traceability.
Three deeply integrated modules that eliminate the data silos killing your compliance efficiency.
Bridge the gap between software development and Design Controls. End-to-end traceability from requirement to test, audit-ready by default.
ISO 13485 and EU MDR compliance without the legacy overhead. Go live in 14 days with best-practice templates and adaptive workflows.
The first MedTech AI assistant built for compliance, not just chat. Write requirements, spot risk gaps, and prepare audit summaries in minutes.
Most companies buy separate tools for R&D and Quality, then spend months trying to make them talk. Orcanos is architected differently: Engineering Design Control (ALM) and eQMS 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
● With Orcanos
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 · Covaris
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.
| Artifact | Status | Linked to |
|---|---|---|
| REQ-042 | ✓ Approved | RISK-12 |
| SRS-007 | ⏳ In Review | TC-88 |
| RISK-12 | ✓ Mitigated | VAL-03 |
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.
Stop digging through SOPs and regulatory documents. Ask Paul answers compliance questions in plain language — surfacing the right artifact, risk, or regulation instantly.
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.
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.
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.
Regulatory submissions require complete, consistent, and traceable documentation. Orcanos structures your DHF, risk management file, and design controls from day one, so when a submission deadline arrives, the evidence is already organized. No last-minute reconstruction. No hunting across systems.
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.
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 | ✓ | ✓ | ✓ | — |
We've removed every excuse to delay.
The fastest medical device QMS implementation on the market.
See Orcanos live with your actual use case - not a generic walk-through. 30 minutes. No sales pressure.
Our MedTech experts map your existing SOPs and data into Orcanos. You keep your process - we adapt to it.
Team trained, data migrated, workflows validated. Most customers go live in under two weeks.
From day one, your data is structured for ISO 13485, EU MDR, and FDA - so audits are never a surprise.
Everything you need to know about our platform, compliance coverage, and getting started.
Orcanos is a cloud-based eQMS 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.
Most Orcanos customers go live within 14 days. Unlike legacy providers that require 3-month onboarding cycles, Orcanos provides out-of-the-box eQMS best practices and a no-code configuration environment — so you're audit-ready from the start.
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.
The eQMS 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.
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.
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.
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.
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.
Join 100+ medical device companies that chose Orcanos to unify quality, development, and risk — without the implementation nightmare.
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