Regulatory Compliance on Atlassian
for FDA approval & CE-marking

SoftComply Risk Manager Plus has quickly become an essential asset for our company at a fair price.

A well-implemented and -documented QMS not only helps us deliver a better product, but it also helps create a safer world for all.

SoftComply Risk Manager is professional, easily configurable, intuitive and very relevant to risk management. This is the better of the risk management add-ons for Jira!

The traceability features of the SoftComply Risk Manager are great, giving the ability to trace risk control implementation and mitigation!

Combining SoftComply Risk Manager Plus with Jira, Confluence and Xray closes the circle between specification – risk – verification – validation very easily. Traceability is key in the ISO13485 standard.

A feature that really stood out in the SoftComply Risk Manager is the risk cloning feature – this helps speed up risk assessments significantly!

SoftComply Risk Manager – overdue, highly useful Risk Management add-on for Medical Device Software (And Hardware) developers who seeks compliance with the ISO 14971 standard and for those using Jira.

I think the SoftComply Risk Manager is suitable not only for Medical Device Manufacturers but also for Safety Critical Software Development in any other Engineering Domains.

The automated Risk Management Plan and Risk Management Report generation into Confluence is a great feature of the SoftComply Risk Manager – this speeds up our Risk Documentation!

The ability to customise the Risk Matrix & define Risk Levels in the SoftComply Risk Manager is great!

Love the summary report being automatically included in the Risk Matrix!

SoftComply Risk Manager Plus is a very useful tool to speed up our ISO 14971 Risk Management for the development of our medical devices. Everything is very customizable and can be tailored to your liking, we even imported our old FMEA excel files to get a head start.

Re-Use is a big thing and it is awesome that with the SoftComply Risk Manager app I can reuse risks, mitigations and verifications!

We were already using Confluence and we then found the SoftComply eQMS app – it is a great fit for us!