Summary SoftComply has released a new Confluence Server macro within the SoftComply eQMS app that allows the user to use any Confluence page as a template, copying it automatically into the existing space at a click of a button. Features include the addition of prefixes, suffixes, timestamp and more. This bypasses the use of Confluence […]
How the MediCompli Solution helped Cibiltech become MDR Compliant on Atlassian Confluence
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 […]
Comparison of SoftComply eQMS & MediCompli Solution
What is a Quality Management System? You probably know that Medical Device companies are required to have a Quality System in place, in order to be able to market their products in most countries in the world. This Quality System, or Quality Management System – QMS, is a collation of Procedures, documents, templates and records […]
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 […]
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 […]
What is MDR Up-Classification and its Extension
For a number of Medical Device companies, Christmas arrived earlier in 2019. On the 17th December 2019, the second Corrigendum to the Medical Device Regulations was formally approved. This has interesting consequences for some Class I devices, that until now would have had to go through the full rigour of the MDR as of the […]
MDR: Equivalence in Clinical Evaluations
Demonstrating equivalence to an existing, marketed medical device has always been a practical way to show that a new device is safe and effective, and lengthy clinical trials are not required. Now, the “new” EU MDR introduce a new variation in the concept of “equivalence” for medical devices. Annex XIV, Part A, Clinical Evaluation lists […]
How SoftComply eQMS helped speed up the CE-marking of munevo DRIVE – a Case Study
“If you are developing medical device software and need to go through the certification process, look what SoftComply has to offer!”, says Claudiu, the co-founder and CEO of Munevo. Munevo is the company behind munevo DRIVE – the first wheelchair control system that uses smart glasses enabling people to become more independent and safely drive […]
How to Set Page Level Restrictions in Confluence?
In our previous blog posts we have described the Confluence Server level access and Space access and will focus on page level restrictions in this blog post. You can get lots of benefits while knowing a few simple tricks about page restrictions. What are page restrictions and why should I use it? According to Atlassian, […]
How to Secure your Documents in Confluence?
This short post will provide you insight into taking control over your document management in Confluence Server. This post is not going to touch regular security policies like VPN, firewalls, security policies and ohter things that are outside of the Confluence Server. In other words, all the really technical things are left out and we […]
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 […]