Orcanos

Orcanos develops a combined electronic Quality Management System (eQMS) and Application Lifecycle Management (ALM) platform designed specifically for medical device companies. The platform is intended to serve R&D and Quality teams simultaneously, providing a single source of truth that connects product development activities with regulatory compliance requirements. Orcanos targets MedTech organizations of varying sizes, from startups seeking initial regulatory clearances to established companies managing ongoing compliance across multiple audits.

The platform is built around the principle that QMS and ALM tools should adapt to a company's existing workflows rather than requiring teams to change their processes to fit the software. Orcanos supports compliance with ISO 13485, EU MDR, ISO 14971, and 21 CFR Part 11, and the company states that customers have used the platform to obtain CE certification and FDA clearance.

Core Platform Modules

• eQMS: A next-generation quality management system with native support for ISO 13485 and EU MDR. The company states customers can go live within 14 days using best-practice templates, bypassing the longer implementation cycles associated with legacy providers.
• Regulated ALM: An integrated ALM environment that bridges software development with regulated Design Controls. It provides end-to-end traceability, automated risk management, and Design History File (DHF) audit readiness within a single validated environment.
• Document Control: Manages the full document lifecycle, including flexible workflow routing, automated PDF publishing, and archiving. The module maintains a centralized, 21 CFR Part 11 compliant repository with a detailed audit trail for every document revision. It also automates "Read and Understand" training tasks that are triggered automatically upon document release.
• Risk Management: Integrates ISO 14971 risk management directly with ALM and QMS data, replacing static Excel-based risk files with a live, connected risk engine. Features include automatic links from requirements to hazards to mitigations, and real-time risk heatmaps for visibility into safety trends. Orcanos states this approach reduces manual risk management costs by approximately 30%.

Key Capabilities

• End-to-End Traceability: Automatically links User Needs, Risks, Requirements, and Validations across the product and quality digital thread, without enforcing a specific document hierarchy.
• Adaptive Workflows: Custom workflows can be built using a no-code, drag-and-drop interface, allowing quality managers to update forms and fields without developer involvement as regulations evolve.
• Granular Access Control: Role-based access control that can be configured to match an organization's specific structure.
• Rich Data Support: Supports a wide variety of field types to capture the specific data points required by the product and regulatory bodies such as the FDA.
• Automated Impact Analysis: When ALM and QMS data are unified, the platform performs automated impact analysis to identify how design changes affect compliance and risk posture.
• AI Assistant — Ask Paul: An AI-powered assistant named Ask Paul, designed to guide users toward operational efficiency within the platform.

Deployment and Implementation

• Orcanos offers a rapid onboarding process, with a stated go-live target of 14 days using pre-built best-practice templates.
• The company provides a data migration service in which its team maps legacy data and spreadsheets into the Orcanos platform, aiming to complete migration in days rather than months while preserving historical records.
• The platform is described as available at any scale, serving both early-stage startups and larger MedTech organizations.

Customer References and Use Cases

• Covaris (Director Quality & Regulatory, Hein Smit Sibinga) reported completing four days of auditing within a ten-day period entirely within the Orcanos platform, without physical binders or document scrambling.
• IceCure (VP R&D, Naum Muchnik) cited Orcanos as an optimal solution for documenting and distributing requirements, noting the support provided during their transition from manual to digital processes.
• ZygoFix (CEO, Ofer Levy) reported obtaining both CE certification and FDA clearance while using Orcanos.

Company Background

• Orcanos was co-founded by Zohar Peretz (Co-Founder, Business Development) and Rami Azulay (Co-Founder, CEO). The leadership team also includes Gil Pry-Dvash as Chief Product Officer and Paul Mullen in an advisory role.
• The company's stated mission is to help organizations achieve and maintain compliance with reduced friction through software tools and services that simplify compliance management and automate processes.

Orcanos positions itself as an alternative to both legacy QMS providers and disconnected point solutions, with its combined eQMS and ALM offering aimed at reducing the compliance overhead that arises when quality and development teams operate in separate systems.