6 Steps to Agile Risk Management Success in Jira for Regulated Environments
Balancing agile development with regulatory compliance feels like trying to mix oil and water. But what if I told you there’s a way to integrate risk management directly into your Jira workflow without sacrificing speed or compliance? Based on a recent webinar with Aaron Morris, I’ve distilled the process into six practical steps that will […]
Why Atlassian Solution Partners Must Pivot to Business Users in 2025
For years, Atlassian solution partners have built successful businesses around helping IT teams configure Jira and Confluence, manage licenses, and handle technical implementations. But that world is rapidly changing. Atlassian is shifting its focus from IT admins to business users in specific departments and industries – and partners who don’t adapt risk being left behind. […]
Beyond Configuration: How Consultants Empower Regulated Industries
For regulated industries – such as Pharma, MedTech, FinTech and Aviation – compliance isn’t optional; it’s mandatory. Tools like Jira and Confluence are powerful, but their true potential is only realized when configured to meet industry-specific regulatory requirements. This is where industry consultants come into play, offering expertise that goes beyond standard configurations – translating […]
How to do FMEA for Medical Devices: Step-by-Step Guide to Risk Management
In the medical device industry, risk management is not just a regulatory requirement. It is a fundamental practice to ensure the safety, effectiveness and quality of devices that directly impact patient health and wellbeing. If you operate within the medical device industry as a manufacturer, Software as a Medical Device (SaMD) developer, OEM supplier or […]
Doccle: How an Integrated Risk Management System paved the road to ISO27001 compliance
Doccle, a leading IT service provider in Belgium that specializes in helping businesses transition to 100% digital invoice administration realized that one of their own central processes – risk management – was not yet fully digitalized. They started a search for an integrated, efficient, and compliance-ready risk management solution within their existing Jira and Confluence […]
How to Prepare for ISO 27001 Compliance in Jira Cloud
Like with any compliance journey, you should first establish why you need to be compliant with a certain regulation. ISO 27001 certification is widely used to build trust and credibility with customers and stakeholders. Similarly, in the Atlassian ecosystem, the requirement of obtaining ISO 27001 certificate applies to Marketplace Partners that wish to retain their […]
Why ISO27001 Should Stay Within Jira for Atlassian Marketplace Partners
Atlassian’s updated Marketplace Partner Program underscores the need for robust security management. With increasing customer expectations around data protection, security, and compliance transparency, Gold and Platinum Marketplace Partners are required to demonstrate adherence to compliance framework like SOC 2 or globally recognised standards such as ISO 27001. This shift is particularly critical for vendors managing […]
How to build Risk Automation with Jira Automation & SoftComply Risk Manager Plus
Risk Manager Plus on Jira Cloud is the most advanced risk management app supporting a wide range of risk management frameworks. You can easily customize the built-in Risk Models or build your own Risk Model from scratch, e.g. 2- or 3-dimensional Risk Matrix or Risk Score based ones. You can also specify your risk assessment parameters […]
How a Compliance Solution on Atlassian Cloud Empowered a Leading MedTech Company
A mid-sized company in the medical technology sector faced a growing challenge: meeting the stringent requirements of the Medical Device Regulation (MDR) and FDA 21 CFR. As the company expanded, the existing ways of managing risks and documentation – such as Excel spreadsheets and paper-based processes – became increasingly inefficient and error-prone. This not only […]
Navigating FDA Cybersecurity Requirements for Medical Devices – A Case Study
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2/IIb device consisting of hardware and software. The company spent about 2 years working on the security risk management of the device. In addition, they also embarked […]
