Marion Lepmets _SoftComply_ Community Champion

This is a fantastic addition to Jira Service Management! Bringing explainable, AI-supported risk assessment directly into change management can help teams identify potential issues earlier and make better-informed approval decisions. It also creates a valuable connection between individual change risks and the…

Hi @Halina Cudakiewicz_Deviniti_ , You asked "when you see teams bring risk management into Jira, what is usually the hardest part?" - these differ from organization to organization (happy to arrange a quick call to tell you more ;) but one thing that stands out is that the compliance (and risk) teams are not always as…

Hi @Abilash , We are going to run a webinar on exactly this topic this Wednesday, March 11: https://softcomply.com/webinar/vendor-risk-management-jira-jsm/ Hope you can join us there! If not, we have written a bit about vendor risk management in Jira here. Hope this helps, Marion (softcomply.com)

Agree 100%, @Halina Cudakiewicz_Deviniti_ The same is true for risk management, especially for product safety risk management that should live where the work is done, i.e. in Jira. Having your requirements, quality and compliance management in a separate tool from your product development will make traceability and…

Thanks, @__ Jimi Wikman! Please let me know in case of any questions. 

@Martin Karlsson sorry for not having seen your comment earlier - you can use our app with any Jira version. Integrated ISMS checklist, built-in ISO27001 controls and automatic generation of your SoA are only available in our Cloud app though.

Hi @Piotr Prusak , Thanks! SoftComply Risk Manager Plus supports ISO 14971 which is the standard for medical device risk management as referred to in the ISO 13485. In case you would like to learn more about it, please don't hesitate to book a call with the team.

Hi @Erin Naismith , You can use the SoftComply Validation app for Confluence Cloud for that. With this app you can run validation checks of your Confluence Cloud instance once a week. Feel free to try it out or book a demo with us to see it in action. Looking forward to talking to you soon, Marion/SoftComply

@Joseph Law (Contegix) thanks so much for this insight and congratulations to all the featured apps and their teams! 🌟 We at SoftComply, advocates of compliance and safety integrated to Jira and Confluence, would like to thank our customers for choosing the SoftComply Risk Manager app to identify, mitigate, track and…

Hi @Kelsey Van Scoy , Thanks! This demo would be in the category of Apps for Business Teams. I couldn't add the appropriate tag myself for some reason.

Looking forward to seeing you soon, @Svenja Lorenzen 

Hi Katie, unfortunately this app is only for Cloud version. 

Hi Mika, this is only for Cloud version unfortunately. 

Hi @Henk Heijmink, In case you need a good overview of the risks in addition to their calculation, there is a number of risk apps for Jira available on Atlassian Marketplace that could come in handy.

Hi @Nikky FinchBrock , We just wrote a post on how to freeze data in Confluence to better monitor progress and store meeting notes (with macros) with the Static Snapshots app - perhaps that could help you. 

Hi @Ronson LeVau We help medical device companies with validation. In case you wish to learn more, please let me know - marion@softcomply.com 

Dear @Paulina Mijal SoftComply Risk Manager app in Jira Cloud has a free extension in Confluence where you can display your risk matrices and risk tables on your Confluence pages/risk reports. Let me know if you'd like to learn more about this. Kind regards, Marion/SoftComply 

Hi @Nikki Zavadska _Appfire_, thanks for this list! We would like to add a few webinars from SoftComply as well: 1. SoftComply webinar and live demo of Risk Management on Jira for safety-critical product developers on February 10 - https://us02web.zoom.us/webinar/register/WN_pC2mtGLITviH3Gwxb1DfLw 2. SoftComply webinar and…

Hi Khai, In case you would like to manage risks in Jira and report them in Confluence, you could try out the SoftComply Risk Manager app. We have just released a Confluence extension to the Risk Manager app on Jira Cloud to make reporting super easy. You can display the Risk Matrices and the Risk Table with all your risks…

Thanks, @Rob Horan We provide our clients with Jira reports that automatically pull in their risk project’s risk matrix configuration with the risk counts as well as Jira dashboard gadget. For visualizing risks in Confluence we have a few video clips on how to create risk traceability matrices/tables in our YouTube…

Hi Johann, You can try out the SoftComply Risk Manager app for automating your risk management process on Jira. https://marketplace.atlassian.com/apps/1216361/softcomply-risk-manager?hosting=cloud&tab=overview Our app comes with several risk management templates for risk matrices and risk table view (provides you with a…

Hi @Abhijith Chunduru , You can read more about the MediCompli solution here https://softcomply.com/medicompli/ (demo form in the bottom of the page) and see a short video of MediCompli here https://youtu.be/tVosqamiUtU. Looking forward to talking to you soon. Kind regards, Marion

Hi @de Chaisemartin , Although we do not provide requirement management apps, we have developed risk management apps on Jira specifically for medtechs based on ISO14971 requirements - https://marketplace.atlassian.com/search?query=softcomply%20risk We have also recently released the MediCompli Solution, an FDA 21 CFR 11…

Hi Clayton, Should you be looking for a software/product risk management app, SoftComply has built one for the safety-critical industry that supports Hazard Analysis and FMEA - https://marketplace.atlassian.com/apps/1216361/softcomply-risk-manager?hosting=cloud&tab=overview. We also run webinars regularly on how to manage…

Hi @Brenda Kelly we have joined forces with Comalatech in developing FDA 21 CFR 11 compliant solution for Confluence. It extends the ISO13485-based SoftComply eQMS with FDA compliant document approval, CAPA, training and change request workflows (built on Comala Document Management and Comala Publishing) and compliant…

Please let us know what exactly would you like to learn about HIPAA and project management in the healthcare domain. Hope that we in SoftComply can help you as we support medical device and digital health companies in regulatory compliance on Atlassian stack. 

Hi Nic, SoftComply has released Risk Manager Plus that supports FMEA risk analysis method with 3 parameters (severity, probability and detectability) https://marketplace.atlassian.com/apps/1219692/softcomply-risk-manager-plus?hosting=server&tab=overview Visualization of risks is done either in risk matrices (initial and…

Hi Tom, You may want to try the SoftComply Risk Manager Plus on Jira for that - https://marketplace.atlassian.com/apps/1219692/softcomply-risk-manager-plus?hosting=server&tab=overview You can use 3 parameters and visualize risks either in Risk Matrices or in RPNs. Hope this helps, Marion

Hi Tom, We have developed the 3-parameter risk management app (SoftComply Risk Manager Plus - https://marketplace.atlassian.com/apps/1219692/softcomply-risk-manager-plus?hosting=server&tab=overview) with Detectability and RPN as an upgrade to our current SoftComply Risk Manager -…

Thanks, LeKisha! We aim to speed up the process of compliance for both cloud and server users so that all the amazing medical innovations would get to market faster.