The Regulatory Compliance Journey of myBioma Biome Diagnostics GmbH is an Austrian medtech start-up utilizing the genetic information of the microbiome and AI to develop medical diagnostic software for doctors. Biome Dx products utilize technologies such as next-generation sequencing, pipeline architectures and microservices. With their lifestyle product myBioma every European has the possibility to learn […]
How to Use Confluence Pages as Templates
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 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 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 […]
SoftComply eQMS for Medical Device Companies has arrived!
SoftComply is pleased to announce SoftComply eQMS, the first Atlassian add-on addressing the needs of life-science, medtech and pharma companies has arrived. SoftComply eQMS: • fast-tracks the implementation of a compliant Quality Management System for medical device companies; • is comprehensively focussed on the EU and US based markets, and helps users fulfil their requirements […]
A Fully Customizable Quality Management System for Your Medical Device Company!
Numerous companies struggle to enter medical device domain due to strict regulatory requirements for medical device products. Similarly, large medical device manufacturers have a difficult time finding suppliers that are not only innovative but also compliant with the regulatory requirements of medical device domain at the same time. A Quality Management System (QMS) is a […]