FMEA Risk Management

Assure ISO 14971 Compliance For Medical Device

FMEA Risk Management

Orcanos FMEA Risk Management Tool helps manage and track risks and hazards of your medical device project, reduces the risk of failure, ensures hazards are mitigated, and prevents failure from happening, all in accordance with ISO 14971.

  • Fully on the web, part-11 compliance e-signature
  • Single repository for Risk ALM and Quality Control
  • Flexible Risk setup
  • Custom queries to better track risk status and unmitigated risks
  • Risk Traceability to design documents and verification test cases
  • Generate a document ready-to-submit of Risk Management File (RMF)

Rami Shoham a Director, QA & RA at Biosense Webster (J&J) Israel


Orcanos | Medical manages all risks in a single location. It intuitively integrates FMEA Risk Management system to the Orcanos ALM (Application Lifecycle Management) Suite, and to the Orcanos Service Center that manages and track Customer Complaints, thus assuring Risk assessment is done for every new customer complaint.

In order to keep your organization safe, Orcanos risk management system has scheduled alerts that notify you on a periodic basis about anomalies in the process, and impact analysis information.

Using Orcanos built in custom query builder and search, you can have a quick and effective access to risk assessment and mitigation activities.

What you can track for example:

  • Risk without mitigation
  • Requirement related to a specific risk, and their verification status
  • Risks with no traceability for mitigation
  • Unverified risks
  • Run Compliance Assesment


Use Orcanos risk management setup for customizing risk settings, such as acceptable and desirable levels of risk, RPN calculation method, naming and special risk attributes, such as “who is affected”, “mitigation type”, setup multiple risk categories and more. Risk assessments can be triggered from any Orcanos module and can be traced to any work item.

Risk Control: Handle the definition and implementation of risk mitigation plans – define which controls are required for the specific risk, and action items, etc.

Risk Verification: Trace test cases to risk in order to assure risk is properly verified. Save results for verification evidence.

Requirements Verification Traceability Matrix
Track and Report


The Orcanos risk management software has a strong risk based dashboard as well as analytic reports that allow defining threshold, that later can trigger alerts and reports to increase team awareness.

Orcanos | DocGen utility generate your RMF  document with the full FMEA table and traceability automatically with no human error, ready for upload into Orcanos e-DMS system for approval using e-signature feature.



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