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 […]
10 Insider Tips from a Notified Body on MDR, AI Act, Audits & Software Tool Validation
If you’re a medical device manufacturer, you already know that compliance isn’t a walk in the park. It’s more like a hike through regulatory terrain with the occasional mountain lion (metaphorically speaking). But don’t panic. We’ve distilled insights from a recent expert-packed webinar to help you navigate the wild world of EU regulations – with […]
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 […]
The Ultimate Guide to ISO 14971 Risk Management
Who Is This Guide For? At SoftComply, we understand the importance of proper risk management. From costly design changes to product recalls and bad press, not accounting for risks is in fact the single biggest gamble that companies are taking today. If you are a medical device manufacturer, marketer, designer, or anyone connected with the […]
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 […]
What does FDA Guidance on Predetermined Change Control Plan mean for Medical Device Manufacturers?
Intro FDA aims to provide a regulatory framework that supports innovation in medical device software development. As such, they understand the need to rapidly change and update software without affecting the safety and effectiveness of the device. In such cases, a new submission shouldn’t always required. But when? Overview In August 2024 the FDA release […]
AI-enabled Medical Devices – FDA Guidance
Intro Medical Devices that contain AI-driven functions have been the focus of Regulatory Agencies in both the EU and the US for the past 2 years, with the FDA taking the lead in releasing regulations and guidance on the matter. On January 6, 2025 the FDA released a new Draft Guidance “Artificial Intelligence-Enabled Device Software Functions: […]
