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.
The majority of our clients are in the USA, the UK & the rest of the Europe – they include start-ups as well as Fortune 500 companies.
A Feature That Really Stood Out In SoftComply Risk Manager Was The Risk-Line Duplication Tool, This Helps Speed Up Risk Assessments Significantly!
SoftComply Risk Manager Is Professional, Easily Configurable, Intuitive, And Very Relevant To Risk Management. This Is Probably The Better Of Risk Management Add-Ons For JIRA!
The Traceability Features Of SoftComply Risk Manager Are Great, Giving The Ability To Trace Risk Control Implementation And Mitigation!
SoftComply Risk Manager – Overdue, Highly Useful, Risk Management Add-On For Medical Device Software (And Hardware) Development To The ISO 14971 Standard For Those Using JIRA And Confluence.
I Think SoftComply Risk Manager Would Also Be Suitable For Those Doing Safety Critical Software Development In Other Engineering Domains.
The Automated Risk Management Plan And Risk Management Report Generation Into Confluence Is A Great Feature Of SoftComply Risk Manager, This Should Speed Up Our Risk Documentation!
The Ability To Customise The Risk Matrix & Define Risk Levels In SoftComply Risk Manager Is Great!
Love The Summary Report Being Automatically Included In The Risk Matrix!
Re-Use Is A Big Thing And It Is Awesome That With Your Risk Management Add-On, I Can Reuse Mitigations!
Summary 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 […]
Read MoreP1 and P2 No we are not talking about the early Playstation versions… ISO 14971 (2019 version, Annex C) indicates that the probability of a Harm occurring can be decomposed in two probabilities, P1 and P2, where: P1 = Probability of Hazardous situation occurring P2 = Probability of Harm occurring for a given Hazardous situation […]
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info@softcomply.com
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