Search Results for: hazard
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
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...
Marion Lepmets
CEO
April 24, 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...
Marion Lepmets
CEO
April 16, 2025
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,...
softcomply_admin
September 30, 2024
Table of Contents 1. QUICK START GUIDE Install the SoftComply Risk Manager Plus from the Atlassian Marketplace to your Jira Server (or Data Center) instance. This step may require Jira administration permission. After the successful installation, click on the “Risk Manager Plus” item on the top navigation bar and select...
softcomply_admin
September 30, 2024
Table of Contents 1. QUICK START GUIDE Open (or create) a Jira Project in which you want to manage your risks. Find the “Risk Management“ tab from the Project panel. Click on the, Risk Model“ and Enable a risk assessment model for your Project, choosing from the list of available...
