Search Results for: hazard
Marion Lepmets
CEO
August 13, 2025
Do you want to make your medical device risk management more precise? While many companies stick with single probability values in their hazard analysis, ISO 14971 suggests breaking down probability into P1 and P2 components. I’ll show you exactly how to set this up in Jira using nested risk models....
Marion Lepmets
CEO
July 29, 2025
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
CEO
July 30, 2024
If your team is working in Jira and you need to conduct hazard analysis, you can do so using the SoftComply Risk Manager Plus app. Hazard analysis is crucial in safety-critical product development, especially for medical devices. If you prefer to watch the video instead of reading, you can do...
Marion Lepmets
CEO
March 21, 2024
What is the difference between Hazard Analysis and FMEA. Which approach should you use. Comparison and examples....
Marion Lepmets
CEO
November 2, 2018
We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users – the SoftComply Risk Manager Plus focusing specifically on safety-critical product/device/system risks. SoftComply Risk Manager Plus supports both Hazard Analysis as well as FME(C)A, including FME(C)A with Detectability and...
Marion Lepmets
CEO
March 30, 2017
From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an inductive technique using the question “What happens if … ?”. Components are analysed one at a time, thus generally looking at a single-fault condition. This is...
Marion Lepmets
CEO
August 19, 2025
Risk reporting isn’t just another checkbox on your compliance list. It’s the backbone of effective risk management that keeps your team informed, your management happy, and your auditors satisfied. When you’re managing risks in Jira, you need clear, current reports that don’t require endless manual updates or screenshot juggling. Watch...
Marion Lepmets
CEO
August 4, 2025
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
CEO
June 19, 2025
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
CEO
May 15, 2025
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...
