SoftComply Risk Manager for Basic Product Risk Management

This Risk Manager free version is useless as you can not make any modification. The paid version is too expensive. It is better to use another free version.

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  SoftComply

  Hi Michael,
  
  The free tier of the Risk Manager works exactly like the higher tiers - in both of them you can make modifications.
  We are happy to demo the features of the app to you but in the meantime please check out the product documentation and please do not forget to review the permissions needed to modify the risk models and tables!
  
  Looking forward to talking to you soon,

  Marion/SoftComply

We are currently using Risk Manager for multiple SaMD projects compliant with 13485 and 14971. Integrating the risks directly in Jira where our teams are already working greatly increases risk visibility, and allows our risk management processes to be folded seamlessly into our agile workflow, with iterative risk reviews and easy to generate documentation when it's time to build the DHF. Features like automatic risk scoring based on a customized matrix, harm-severity lock, and traceability to other work items in jira using issue links really set this addon apart from the obligatory risk spreadsheets. Since we're also tracking all of our requirements and testing in Jira, everything can be in one place, and linked together, making traceability easy, dynamic, and finalizing our documentation is much faster, allowing us to get from development to submission in less time.

If you have to manage risks for your products or processes, you will properly have tried to use a big Excel table. And you properly hated it… The SoftComply Risk Manager is, despite some potential for improving the UI, a far better solution. And since every risk is also a Jira issue, it is quite easy to link it with your development tickets. If you have to or want to manage risks for your products or processes, and you are already using Jira, we from Skinuvita strongly recommend that you give the SoftComply Risk Manager a chance.

I have been using SoftComply Risk Manager for the past year and can thoroughly recommend it. The GIU is very good and intuitive and being part of JIRA, enables linking nonconformities and improvement opportunism directly to the related risks. Guðjón Vidar Valdimarsson (CISM,CISA,CIA,CFSA,CIPP/e) Quality and security Manager Registers Iceland

Risk manager is an excellent Plugin from Soft Comply supporting Jira Service management and Jira software. I would definitely recommend to other customers.