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

Information Security Risk Management Guide

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 […]

Jira Risk Management Workflow Tutorial

In this article, we will look at the 4 steps needed to build a Risk Register in Jira. For those of you fluent in Jira, this tutorial will be focusing on risk lifecycle management not the native Jira issue workflows. What is a Risk Register and why create it in Jira? The document where an […]

Using Jira for Risk Management: 8 Best Practices For 2024

When it comes to managing risks in project management, using Jira for risk management can significantly improve your team’s productivity and effectiveness. Risk management involves identifying, assessing, and prioritizing risks to minimize their impact. With Jira’s flexible tools and plugins, you can streamline this process making it easier to keep track of potential issues and […]

5 Steps To Tracking & Mitigating Project Risks in Jira

Risk Management in Jira with SoftComply

Project risk management is crucial for project success, especially important to keep critical risks under check in case of (inevitable) changes. The hidden complexities of a project is the main reason why timelines are not met and the resources are spent mid-way. Here is a quick guide for a Project Manager how to best conduct […]

Supporting Regulated Industries on Atlassian

On May 2, 2024 SoftComply hosted the 2nd edition of Regulated Industries workshop during Atlassian Team event. The workshop’s title was “How to best support Regulated Industries on Atlassian” and was aimed to discuss the customer feedback and best practices of collaboration between Atlassian, app vendors and solution partners to support our customers. For 2 […]

What are the FDA 21 CFR 11 Compliant Electronic Records?

Title 21 of the Code of Federal Regulations, Part 11, also known as 21 CFR 11, deals with the requirements for Electronic Records and Electronic Signatures to be considered “trustworthy” by the FDA. If you work in the MedTech or Pharma sector, you probably have heard about this regulation plenty of times. And if you […]