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).

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.

Additional reading on Medical Device Regulations and Compliance Solutions that you may want to check out:

Short Clip of SoftComply Presentation at Medica2018

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.