SoftComply Risk Manager is an Atlassian Jira app for managing, tracing and reporting your risks.
SoftComply Risk Manager Plus is an Atlassian Jira app for managing, tracing, visualising and reporting your safety-critical product risks.
SoftComply eQMS is a full Medical Device QMS developed as an app on Atlassian Confluence.
SoftComply Static Snapshots is an Atlassian Confluence app for taking and storing Confluence content in a static form.
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!
If you have worked with Jira and Confluence, am sure you have enjoyed the integration between the two. The way you can easily pull data from Jira to Confluence by creating macros on your Confluence page with all the data from Jira that you want to display is absolutely wonderful. Now, every time you refresh […]
Read MoreThe relationship between the FDA and ISO 13485 goes back a long time. The ISO standard has been in the list of General Consensus Standards since the dawn of times, but there has never been a full alignment between 21 CFR 820 (QSR) and ISO 13485. It’s like these couples that have been together forever, […]
Read MoreThis is the ultimate Risk Management Guide for a Digital Health or a Medical Device Company on Jira Cloud. This guide provides information on why and how a digital health or a medical device company should manage their product risks, what features should a risk management solution have and how to best set up compliant risk management process on Jira Cloud with SoftComply Risk Manager.
Read MoreSoftComply Ltd
+372 5303 9216
Munich Office:
Bavariaring 24
Munich 80336
Germany
