Continuous Realtime Audit

For Medical Device

Integrating Design Control, Quality And Regulation Compliance

Trusted By

design control, quality, regulation


The quality journey for medical device companies is rarely simple. There are likely to be numerous hurdles to clear, many of which can have a bearing on how quickly a product comes to market. More often than not, the product lifecycle needs boxes to be ticked from the moment that an idea is born until the time it becomes a working device in the healthcare sector.

Orcanos integrates Design Control (Application Lifecycle Management), a formalized Quality Management System (QMS) and the keys to Regulatory Compliance in one central access point. End users can also generate data into Microsoft Office tools at any point, and either export them for e-signature in the Orcanos Document Management System or directly sign the electronic records. 


Understanding and appreciating risk is an inherent part of any product lifecycle. Continuous visibility for stakeholders is key, and identified hazards must be mitigated before a product failure becomes a problem. 

Orcanos audit tools integrate Risk Management into the various stages of product development and QMS processes, generating actionable data with a single click. In fact, our research has shown that companies can save up to 30 percent of the resources allocated to manual risk management by leveraging our ISO 14971 compliant software.

fmea risk management
orcanos electronic forms QMS


Paper-based QMS processes can be a bottleneck in the race to get a product to market. Orcanos replaces the traditional method of submitting required documentation with electronic forms, which can have a positive impact on both productivity and efficiency. 

Our solution includes the following upgrades to paper-based quality processes:

  • Intuitive customization tools that incorporate simple templates
  • Support for a wide variety of field types
  • Effective workflow routing for e-signature  (21 CFR Part 11 compliant)
  • E-form traceability across the entire process
  • Ability to set up logical steps to comply with mandatory rules
  • Access control for end user inputs such as Add/Edit/View
  • Filters 
  • Drag and drop interface, no coding required!

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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