SoftComply Risk Manager is an add-on for Atlassian Jira to manage, trace and report your product risks.
SoftComply Risk Manager Plus is an add-on for Atlassian Jira to manage, trace and report your safety-critical product risks.
SoftComply eQMS is a full medical device Quality Management System developed as an add-on for Atlassian Confluence.
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!
The Regulatory Compliance Journey of XRGO Nathaniel Victor, CEO of XRGO: “We got involved in PPE manufacturing as a goodwill donation/gesture of time, energy, products and financial support to the hospitals and local municipalities. Early on, our suppliers in China informed us that COVID-19 was serious and they advised that we protect our staff and […]
Read MoreSummary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]
Read MoreCustomer Story on the MediCompli Solution at Cibiltech Cibiltech Cibiltech is a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution is aimed at post-transplant kidney monitoring for personalized treatment and better decision support. Previous Document Management System at Cibiltech Prior to the MediCompli […]
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