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Marion Lepmets
Risk management in the medical device industry isn’t optional – it’s literally life or death. If you’re developing medical devices, you need to identify, assess, and mitigate risks throughout your entire product lifecycle. Patient safety depends on it. Watch this step-by-step guide to implementing FMEA for medical device risk management....
Marion Lepmets
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...
Marion Lepmets
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...
Marion Lepmets
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...
Monika Isak
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...
Marion Lepmets
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...
