Morris Medical Monthly: Overview of RiskPack Data Types

Welcome back to Morris Medical Monthly: a monthly series for medical device development companies – and companies who are related to such companies – providing useful information about Polarion solutions and Polarion extensions.

Today we will discuss the subject of Polarion’s RiskPack extension, and have a look at RiskPack Data Types.

The RiskPack works with six different types of elements:

  • Risks

  • Harms

  • Sequences of Events

  • Risk Control Measures

  • Device Elements

  • Environment Elements

The first four elements are an integral part of Risk Management according to ISO14971. Device Elements represent parts of your device (hardware or software) and Environment Elements are intangible entities, such as hazardous situations.

Because RiskPack doesn’t want to force you to only use the given RiskPack configuration, the RiskPack can be configured in a flexible manner. Your preferred risk management items can be mapped to one of the RiskPack’s data types.

This way you can assign several different work item types to RiskPack types and you are able to yield  information you don’t want to supply.

You do not want to deal with Hazardous Situations? That’s fine!

You want to use your established items like Software Units or Hardware Components? That’s fine, too!

You choose the granularity of the provided information. Simply leave off what you don’t need and take into account what’s important to you or your auditor.

  • Data Type “Harm” (harm)

  • Data Type “Sequence of Events” (sequenceOfEvents)

  • Data Type “Risk Control Measure” (riskControlMeasure)

  • Data Type “Risk” (risk)

  • Data Type “Device Element” (deviceElement)

  • Data Type “Environment Element” (environmentElement)

In the future, I will describe these different data types in more detail.

For more information about Polarion’s RiskPack, please visit this page.

I hope you liked this article and will visit our blog again when there is another Morris Medical Monthly article.

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