SoftComply has developed an Atlassian app for the risk management of medical devices, which automates risk management for medical device companies and integrates it to Atlassian Jira.
“SoftComply Risk Manager is an app for Jira to manage, trace and report medical device risks,” explains Marion Lepmets, co-founder and CEO of SoftComply. “It has been developed for medical device companies and is based on the standard ISO14971. SoftComply apps speed up regulatory compliance for CE marking and FDA approval through automating the implementation of QMS and the device risk management.”
“We help medical device software companies get their innovative products to market faster by offering Atlassian apps for regulatory compliance,” she adds.
SoftComply tested its product at the Aalborg University Hospital in Denmark. “We heard about ProVaHealth project from Tallinn Science Park Tehnopol,” Lepmets says. “Since the living labs involved in the project were able to decide for themselves which product they would like to test, we wrote our application, more specifically about the validation of our Risk Management app, and hoped that someone would be interested in testing it. This is how the danish living lab conducted our product testing and helped document our product validation report.”
At the test site, the software was validated in detail and checked against the relevant standards and procedures in the field. The overall feedback was positive, and some specific suggestions for improvements were made based on the test results.
“Testing our new product using an external expert gave us the confidence that it works exactly as planned,” she describes their experience. “We also received useful feedback on the interface and usability of the app.”
“Our product SoftComply Risk Manager Plus is mainly used in the US, the UK, Germany, and Australia,” she points out. “It is an Atlassian Jira app for medical device developers who need to manage their device risks during their development and throughout the lifespan of the product.”