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FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service.

Contrary to a typical Hazard Analysis (required by ISO 14971), FMEA is a bottom-up approach, meaning that it starts at a low level of the product or process, working its way up to the effects to the system of subsystems.

Although ISO 14971 requires only to identify and analyze hazards, thus suggesting a Top-Down approach, it is a best practice among safety-critical system developers to complement it with a Bottom-Up analysis, i.e. a FME(C)A.

The purpose of this combined approach is to ensure all risks and faults are captured during the analysis. The two approaches will have many scenarios in common, but this redundancy will also provide additional failures that may have been missed using only one method.

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SoftComply Risk Manager Plus supports both Hazard Analysis as well as FME(C)A, including FME(C)A with Detectability and RPN (Risk Prioritization Number).

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Benefits of the SoftComply Risk Manager PLUS for Jira Server:

▪ Supports Hazard Analysis and FMEA
▪ Supports FMEA with Detectability
▪ Displays risks in Matrices & RPN
▪ Supports FDA approval and CE-marking process
▪ Targeted towards safety critical domain users
Supports Hazard Analysis and FMEA
Supports FMEA with Detectability
Displays risks in Matrices & RPN
Supports FDA approval and CE-marking process
Targeted towards safety critical domain users

For full list of features of SoftComply Risk Manager PLUS, please check out the User Guide.

Try it out for free for a month and/or contact us to get a demo & discussion about the features.

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Benefits of the SoftComply Risk Manager:

▪ Supports any software system/product risk management
▪ For both Jira Server & Cloud users
▪ Fully customizable for any type of risk project
▪ Automated traceability
▪ Support software system/product risk management
▪ Most competitive price
Supports any software system/product risk management
For both Jira Server & Cloud users
Fully customizable for any type of risk project
Automated traceability
Support software system/product risk management
Most competitive price
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Benefits of the SoftComply eQMS:

▪ Full Quality Management System for medical device co-s
▪ Based on ISO13485, IEC62304, ISO14971 & FDA 21CFR 820
▪ Fully customizable with embedded guidance
▪ Reduces the cost of compliance
▪ Most competitive price
Full Quality Management System for medical device co-s
Based on ISO13485, IEC62304, ISO14971 & FDA 21CFR 820
Fully customizable with embedded guidance
Reduces the cost of compliance
Most competitive price

SoftComply eQMS on Confluence Cloud:

The new MDR states that Quality System documents need to be searchable. You can now implement a compliant Quality System documentation on your Confluence Cloud! Access the free trial version directly from the Atlassian Marketplace.

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