Customer Story on the MediCompli Solution at Cibiltech Cibiltech Cibiltech is a French medical device company developing an AI based personalized medicine solution for better patient care. Their most recent solution is aimed at post-transplant kidney monitoring for personalized treatment and better decision support. Previous Document Management System at Cibiltech Prior to the MediCompli Soluton, […]
How to Turn Confluence into a Compliant Document Management System for Medical Devices
WHY CONFLUENCE? Most medical device companies need to have at least a compliant quality management system in place, not to mention the quality records that will always need to be generated during the lifecycle of the device. With your software development team using Jira, it is natural that your organisation would like to have everything […]
What is a Risk Management File?
ISO 14971:2019 defines the Risk Management file as a “set of records and other documents that are produced by risk management”. In practice, the risk management file must contain, or have reference to, the following documents: (4.2, Note 3) The policy for establishing criteria for risk acceptability. (4.4) The Risk Management Plan. (4.5) Traceability for […]
How to Create an Organisational Risk Register with SoftComply Risk Manager?
Abstract The aim of this blog post is to guide you through the creation of an organisation-wide Risk Register with SoftComply Risk Manager. This Risk Register supports risk management across your organisation providing your team members with a list of risks that apply to a specific product or project. To achieve that, we will first […]
Comparison of Risk Management Apps on Jira Cloud
Following our previous post where we compared the 4 top risk management apps on Jira Server, in this post we are comparing the features of the 2 most popular risk management apps on Jira Cloud. One of them is for product and project risk management (SoftComply Risk Manager) and the other for organisational risk management (Risk […]
SoftComply offers Free Apps to get More Ventilators and Test Kits for COVID-19 to Market Faster
Medical equipment at the Columbus Covid-2 Hospital, in Rome, on March 16, 2020 from The Globe and Mail With the lack of medical equipment in light of the rapid spread of COVID-19 and the hospitalization of infected people (1), SoftComply offers their support to medical device companies. Medical device companies are currently working non-stop to […]
SoftComply at Atlassian Summit 2020
Let’s meet up & talk about Compliance on Atlassian Stack! Tue, 31 Mar 2020 – Thu, 02 Apr 2020 SoftComply Stand: 1319 We support regulated industries on Atlassian stack by offering compliance solutions and services on Atlassian Jira and Confluence.
Six Must-Have Atlassian Apps for MedTech Companies
Which tools should I pick from the Atlassian stack? Jira? Jira Software? Jira Core? And then there is a marketplace full of apps that sit on Jira and Confluence. Can I pick one from there or do I need apps at all? These and many similar questions are asked by almost all new Atlassian users […]
How to Manage Safety-Critical Product Risks in Jira – New Features of SoftComply Risk Manager and Risk Manager Plus
Risk management is a regulatory requirement for safety-critical products. Without compliant risk management most of these products cannot reach their users. With more and more software in safety critical products like medical devices or cars, software developers now also have to manage the risks during the development to ensure the safety of these products. The […]
How to control your electronic Quality Management System in Confluence
In order to have a safe, traceable and manageable Quality Management System in Confluence we need to first take care of our user management. Controlled actions performed by the right people is the cornerstone of developing a safe product. Let’s first review a few definitions, we will then describe the goal of Quality Management System […]
What is Software Tool Validation?
Modern medical device regulations are putting more and more emphasis on the management of software tools. These tools are software packages that are not part of the medical devices themselves, but support the device during its lifecycle. Nowadays companies use dozens of applications, ranging from accounting tools to email clients to software compilers. Of course […]
How to Become Compliant on Jira and Confluence with Comalatech and SoftComply
Written together with Mike Rink of Comalatech Until recently, the Medical Device industry was comprised of a handful of large and well-established hardware manufacturing organizations. As those devices have become more software-driven, so too have software development companies begun working closer with the medical device manufacturers. In addition to supplying software to those manufacturers, these […]