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 […]
Information Security (ISO 27001) Risk Management Best Practices for 2025
Keeping your data safe is vital for every business. One way to do this is by following ISO 27001. But how can we manage these information security risks with a tool like Jira? Let’s dive in! What is Information Security Risk Management Information Security Risk Management is all about identifying, assessing, and managing risks to […]
How to use CVSS in Jira
What is CVSS and when to use it? The Common Vulnerability Scoring System (CVSS) is a standardized framework for rating the severity of security vulnerabilities. The CVSS was developed and is maintained by the Forum of Incident Response and Security Teams (FIRST). FIRST is an international consortium that aims to foster cooperation and coordination in […]
Don’t Keep a Risk Register in Excel (Use Jira)
If you’re considering using Excel for your risk register, this video explains why that might not be the best choice. Instead, we introduce a more effective alternative using Jira and dedicated risk management plugins. If you prefer watching over reading, check out the full video. Key Takeaways: What is a Risk Register The document where […]
