Continuous Realtime Audit

For Medical Device

Integrating Design Control, Quality And Regulation Compliance

Trusted By

design control, quality, regulation


Integrating Design Control (ALM) with a quality management system and regulatory compliance in a central repository. A simple, Part 11 validated system that satisfies the needs of the QA RA and R&D departments, supports embedded products – Software, Hardware, and automates End to end traceability across entities. At any point, Orcanos enables you to generate data into Word documents and e-sign them in Orcanos DMS, or directly sign electronic records


Integrate risk into your development, and to your QMS, to assure full traceability, and save 30% of the resources spent on manual management.

Ensures hazards are mitigated and prevents failure from happening

Generate Risk Management File in just one-click

ISO 14971 Compliance

fmea risk management
orcanos electronic forms QMS


Replace paper-based QMS with Orcanos electronic forms, and achieve higher productivity and efficiency

  • Powerful customization tools, simple templates.
  • Support a wide variety of field types.
  • Build workflow routing for electronic signature (Part 11 Compliance)
  • Setup traceability between different e-forms
  • Setup form logic such as mandatory rules
  • Access control for Add/Edit/View to show/ hide form elements.
  • Integrate filters into field values.
  • No coding is required, drag and drop design

Our Clients Testimonials

“ORCANOS Medical provided a platform to easily deal with complexities entailed in capturing and managing of Product Requirements (System, Software, Hardware, Mechanical, etc) , Risks Management and Traceability in a highly regulated environment…”


Igor Stankovski

Technical Program Manager, Fio

“Orcanos ALM allows us to build our business strategy KPI’s and see the quality of our processes and the efficiency of our program execution to meet the market demands…”

Mazor Robotics

Eli Zehavi

Co-Founder, Mazor Robotics

UP n Ride

Oren Tamari

CEO, Upnride

“…Acting as single repository for all traceability artifact within the DHF/Technical File, warranting the success of any audit…”

Key Features


Combine Design Control (ALM) with quality management system and regulation in a central repository

Document Generator

Easily generate ready for submission documents from your database

Integrated Risk Management

Integrate risk into your development, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971

21 CFR Part 11 Compliance

Define electronic signature process for a complete documents approval lifecycle

Easy Customization

Powerful customization tools to customize your quality forms (CAPA, ECO, Non-Conformity…), E-sign processes, status flows, mandatory rules and permissions 

Dashboards And Analytics

Better tracking and control with custom reports and charts builder, to track projects progress and quality procedures status, such as requirements traceability, test run results, risk assessment, CAPA and more

End To End Traceability

Link any artifact in your process, such as requirements to test cases, risk to complaint, CAPA to ECO and track missing traceability

Realtime Alerts

Alerts come into play when process-critical inconsistencies occur, such as New risk or outdated documents. Alerts are automatically fired once a day/week

gohnson & gohnson
Mazor Robotics
Biosense Webster
Fio Corporation


8 Tozeret Ha'aretz Street
Tel Aviv, Israel

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