Quality Management System

Eliminate paper-based quality processes while adhering to strict MDR/ FDA regulations and ISO quality standards.

Quality Management System
gohnson & gohnson
Mazor Robotics
Biosense Webster
Fio Corporation

Orcanos quality management system keeps all the information required in order to control the quality processes in a single point of access. It enables companies to eliminate paper-based quality processes while adhering to strict FDA regulations and ISO quality standards.

Orcanos medical software replaces paper based quality modules, such as e-DMS, e-DHR, Complaints Management, FMEA RISK Management, CAPA, ECO, Non-Conformities, Engineering for Verification & Validation (Requirements Management, Test Management, Defect Tracking) improving the company’s ability to comply with regulations and quality standards, and much more.

Orcanos e-QMS infrastructure provides professional and easy to use tools, that allows you to build your quality management system within hours. It includes:

  • Electronic forms with e-sign
  • Tractability tool
  • ISO 13485, ISO 9001 support
  • Automatic work-flows for any QMS form such as CAPA, ECO
  • Professional dashboard to track and control your information
  • Compliance A.I Engine monitoring your data in real time.
Document Control Software System

Document Control Software System

Orcanos e-DMS a document control software systems, designed by industry professionals,  allow you to quickly create, archive, trace, search and approve all documentation related to the planning, design, development, manufacturing, and service of a medical device product.

Orcanos e-DMS supports any document type such as user manuals, procedures, forms, work instructions, product specifications, inspections test protocols, nonconformity and much more.

It reduces overall compliance cost and increases efficiency to accelerate time to market.

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ISO 14971: Risk Management

One of the most important modules of any QMS is the risk management (for medical it’s the famous ISO 14971 edition 2012). Applying good risk management practice as an integral part of your R&D, post marketing surveillance or other quality events such as CAPA is critical in case your product has safety related issues. The ability to effectively identify risks in your products and processes, mitigate potential risk and assure verification, is important to ensure the highest level of quality. Orcanos integrated FMEA module for risk management (failure modes and effects analysis) provides a complete and accurate picture of the risk landscape across product lines, business processes and allows better analysis of risks, and by using the traceability tool, you can integrate any risk to any e-QMS item, such as nonconformity, customer complaint or design artifacts for risk mitigation. Using Orcanos e-QMS FMEA module reduces the time spent on studying effects, and mitigate the risk of potential failures.

Orcanos Medical FMEA software is just one of the dozens of modules within the Orcanos quality control system.

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FMEA Risk Management
Electronic Quality Management System

Change Management (ECO)

Orcanos engineering change order (ECO) management system electronically document and control your ongoing change processes, such as SOP’s, design specs, etc., thus enhance a company’s productivity.

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Complaint Handling

Using Orcanos complaint management system helps you manage all those challenges for your medical device project, and support the ISO 13485 post surveillance procedure, particularly in the areas of complaint handling, and labeling control.

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Engineering Change Order
CAPA Medical Device

CAPA Management

Orcanos CAPA (corrective action and preventive action) improves organization’s processes taken to eliminate causes of non-conformity or other undesirable situations. it automates CAPA process completely, such as routing and notifications, and supports all phases of CAPA process from initiation to investigation closure.

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