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 […]
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 […]
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 […]
Introducing Advanced Cybersecurity Risk Management on Jira Cloud
The Role of Cybersecurity in Medical Device Safety The Global medical device market is a $800 billion business that is rapidly growing, especially in the area of software as a medical device (SaMD). The majority of the SaMD segment is made up of the digital health and digital therapeutics solutions, where medical devices are made […]
