eQMS & ALM Platform

Orcanos is a combined electronic Quality Management System (eQMS) and Application Lifecycle Management (ALM) platform designed for medical device companies. It targets R&D and Quality teams that need to manage design controls, risk, documentation, and regulatory compliance within a single environment. The platform supports standards including ISO 13485, EU MDR, ISO 14971, and 21 CFR Part 11, and is positioned for organizations ranging from startups to established MedTech companies.

Orcanos is structured around the idea of unifying ALM and QMS into one source of truth, eliminating data silos between R&D, Quality, and Operations teams. The platform includes an AI-powered assistant called Ask Paul, and claims a deployment timeline of 14 days, contrasting with longer implementation cycles associated with legacy systems.

eQMS Capabilities

• Native support for ISO 13485 and EU MDR compliance, with audit-ready data maintained continuously.
• Automated document lifecycle management, including flexible workflow routing, automated PDF publishing, and archiving.
• Centralized document repository compliant with 21 CFR Part 11, with a detailed audit trail for every document revision.
• Training automation that fires "Read and Understand" tasks automatically upon document release to keep team members current.
• Electronic signatures, mandatory fields, and status flows built into the system to enforce compliance at the workflow level.

ALM and Design Control

• Integrated ALM platform that connects software development workflows with regulated Design Controls.
• End-to-end traceability linking User Needs, Risks, and Validations automatically.
• Design History File (DHF) audit readiness maintained within a single validated environment.
• Automated impact analysis across product and Quality teams when design changes occur.
• Traceability that connects artifacts across the digital thread without enforcing a specific document hierarchy.

Risk Management

• Risk management aligned with ISO 14971, integrated directly with ALM and QMS data rather than managed in separate spreadsheets.
• Automatic links from requirements to hazards to mitigations, providing live traceability.
• Real-time risk heatmaps for visibility into critical safety trends.
• Risk profile updates automatically with every design change, reducing manual management overhead.

Adaptive Compliance and Customization

• Custom workflow builder using a no-code, drag-and-drop interface, allowing quality managers to update forms and fields without developer involvement.
• Granular access control configurable to match organizational structure.
• Support for a wide variety of field types to capture product-specific and regulatory data requirements.
• Platform can be tailored to existing SOPs, status flows, and permission levels rather than requiring teams to change their processes.

Deployment and Migration

• Go-live target of 14 days using best practice templates.
• Migration support provided by the Orcanos team, mapping legacy data and spreadsheets into the platform to preserve historical digital thread records.
• Available at any scale, from startup to enterprise.

Key Workflow Benefits Addressed

• Continuous audit readiness to handle surprise FDA, MDR, and global regulatory audits without manual document scrambling.
• Automated compliance processes intended to reduce bottlenecks in documentation and approval workflows that delay product launches.
• Automatic risk and regulatory impact assessment triggered by every design change, closing traceability matrix gaps before regulatory review.
• Centralized repository eliminating version discrepancies between R&D, Quality, and Operations teams.

Orcanos is a cloud-based platform with reported customer use cases including successful CE certification and FDA clearance. Customers have cited the platform's centralized structure as enabling multi-day audit sequences to be handled entirely within the system, without physical binders or manual document retrieval.