We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users - the SoftComply Risk Manager Plus focusing specifically on safety-critical product/device/system risks.

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).

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.

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:

Visit us at MEDICA 2018 in November in Düsseldorf, Germany!

We are looking forward to meeting you at our stand in Hall 15, Stand B57

SoftComply's New Website!

SoftComply website has got a new look & feel to it!

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.