Risk Management Software: Buyer’s Guide for 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 sophisticated attacks. According to the […]
Compliance Workshop Recap from Team25
Compliance is (finally) on everyone’s radar now that Atlassian is targeting business teams and business users in specific verticals and everyone is talking about solutions rather than apps. This is also why SoftComply hosted the 3rd edition of the Compliance Workshop on April 10, 2025 during Atlassian Team event. The workshop’s title was “How to […]
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 […]
Why ISO27001 Should Stay Within Jira for Atlassian Marketplace Partners
Atlassian’s updated Marketplace Partner Program underscores the need for robust security management. With increasing customer expectations around data protection, security, and compliance transparency, Gold and Platinum Marketplace Partners are required to demonstrate adherence to compliance framework like SOC 2 or globally recognised standards such as ISO 27001. This shift is particularly critical for vendors managing […]
How to build Risk Automation with Jira Automation & SoftComply Risk Manager Plus
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 also specify your risk assessment parameters […]
What does FDA Guidance on Predetermined Change Control Plan mean for Medical Device Manufacturers?
Intro FDA aims to provide a regulatory framework that supports innovation in medical device software development. As such, they understand the need to rapidly change and update software without affecting the safety and effectiveness of the device. In such cases, a new submission shouldn’t always required. But when? Overview In August 2024 the FDA release […]
ISO 13485 Implementation Guide for Startups in 2025
The Internet is full of articles about the implementation of ISO 13485. They talk about “Getting management support”, “Obtain The Documents And Study The Requirements”, “Develop An Implementation Plan”, “Evolution of a Quality Management System”, and other seemingly complex topics. Although comprehensive, most of these articles are self-serving, aimed at promoting specific services of the […]
Software as a Medical Device (SaMD) Startup Guide to Compliance for 2025
Introduction The first contact with the Medical Device regulatory world is a shock for most startups. These companies usually have excellent technical and clinical ideas on how to improve the patient’s life, but little knowledge of the legal burdens required to bring the medical device to the market. The technical world of reasonable certainties clashes […]
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 […]
