Orcanos Risk Management software includes a risk-based dashboard and access to analytic reports that can define a risk threshold. These embedded features can help trigger risk alerts and reports and increase team awareness of a product issue.The integration of ALM and QMS enables a state-of-the-art risk assessment. One repository risk could be managed at the very right moment, reducing time and costs through the product lifecycle.
With full adaptiveness, whether you use PFMEA, UFMEA, or DFMEA, you can customize your risk system to support ISO 14971 fully. So, you can easily set and define the suitable process for your organization.
ISO 1479 Compliance and FMEA support
ISO 14971:2019, which is required for medical device manufacturers, is already inside. FMEA is an acceptable method used to prevent failure from happening. The result is that changes in any design related to the product are automatically evaluated risk-wise and in line with updated regulations.
Be sure to use updated models and methods to determine where you should be involved in making everything safer.
Focus on what to do instead of what not to do. All risks are being managed with minimum intervention from your side.
Be sure to use updated models and methods to determine where you should be involved in making everything safer.
Focus on what to do instead of what not to do. All risks are being managed with minimum intervention from your side.
Assess the impact of the residual risk automatically.
Orcanos’ Risk Management system has an integrated alert mechanism that notifies end-users and stakeholders about any anomalies in the compliance process, generating a breakdown of impact analysis and actionable insights.
The alerts come into play when process-critical inconsistencies occur, such as changes in design or new risks. It all automatically and fired as you defined. Test cases can be traced quickly to ensure that risks are verified and meet the intended use.
Be sure you get notified when a new risk occurs or a failure is about to happen.
Prevents you from making a U-turn or reversing design because the risk is managed late within the process.
Be sure you get notified when a new risk occurs or a failure is about to happen.
Prevents you from making a U-turn or reversing design because the risk is managed late within the process.
Do you have your own way to manage risks? No problem.
Our risk management system is fully adaptive, and you can set up electronic risk forms quickly, define mandatory rules and access control, and workflow for sign-off. That’s why it is suitable for enterprises as well as small and medium businesses.
Create a tailor-made model and processes and define your intervention points to ensure everything is in place from your perspective.
Get understandable forms and simple processes to guarantee your work is efficient risk-wise.
Create a tailor-made model and processes and define your intervention points to ensure everything is in place from your perspective.
Get understandable forms and simple processes to guarantee your work is efficient risk-wise.
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