Search Results for: risk

6 Steps to Agile Risk Management in Jira
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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...

Agile Risk Management in Jira
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Marion Lepmets

CEO
June 6, 2025
At this webinar, we bring you a step by step guide of how to implement agile risk management in Jira that is compliant with medical device software development and risk management regulatory requirements....
medical device risk management guide for FMEA
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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...

Risk Management Software Buyers Guide
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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...

Ultimate Guide to ISO 14971 Risk Management
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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,...

Doccle Case Study
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Monika Isak

Head of Growth
March 24, 2025

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...

RMP Automation
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Marion Lepmets

CEO
February 19, 2025

Risk Manager Plus on Jira Cloud is the most advanced risk management app supporting a wide range of risk management frameworks. You can easily customize the built-in Risk Models or build your own Risk Model from scratch, e.g. 2- or 3-dimensional Risk Matrix or Risk Score based ones. You can...

Org Risk Flyer
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Marion Lepmets

CEO
February 13, 2025
At this forum, industry experts will discuss the importance of organisational risk management in safety-critical domains like aviation and healthcare industries. The forum explores the best known mistakes some of the largest organisations have made and how the rest of us can learn from them. We will also talk about...
ZendraHealthLogo_Text-e1657789670534-105x105-c 2
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Monika Isak

Head of Growth
January 8, 2025

As we are managing our ISMS in Confluence and JIRA, I was looking for an integrated Risk Management system. With this product we now have the perfect solution: we have implemented the product for our information risks, business risks, supplier and product risks. The good thing is that it also...

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softcomply_admin

November 19, 2024

Table of Contents SoftComply Risk Manager for Confluence is an extension of the SoftComply Risk Manager apps on Jira Cloud to visualize and report risks in Confluence. With this app you are able to create Risk Reports in Confluence. You will be able to add the Risk Matrices, Risk Tables...