Complete Guide to Medical Device Hazard Analysis based on ISO 14971 and IEC 62304
Medical device risk management isn’t just another regulatory checkbox. It’s the foundation that proves your device is safe for patients and users. When auditors come knocking, they’ll scrutinize your risk management process more than almost anything else. Get it wrong and you’re looking at serious compliance issues. I’ve put together this comprehensive guide to walk […]
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 […]
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 […]
Risk Management Software: Buyer’s Guide for 2025
INTRODUCTION If you are a risk management professional or business owner, you understand that organizations today face a complex risk landscape driven by technological advancements, evolving regulatory frameworks, and globalization. Developments in AI, cloud computing, and IoT have introduced significant risks, with cybercriminals using these same tools to launch more sophisticated attacks. According to the […]
Compliance Workshop Recap from Team25
Compliance is (finally) on everyone’s radar now that Atlassian is targeting business teams and business users in specific verticals and everyone is talking about solutions rather than apps. This is also why SoftComply hosted the 3rd edition of the Compliance Workshop on April 10, 2025 during Atlassian Team event. The workshop’s title was “How to […]
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 […]
