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 […]
What is Document Control? Automated vs Paper-Based?
Although this process can be extremely complicated and interlaced in large corporations, the requirements for Document Control are actually quite simple. Let’s give a look at them: ISO 13485:2016 – it’s all in two paragraphs, §4.2.4 and §4.2.5: (a) Documents must be approved, i.e. have signatures (electronic or handwritten); (b) If reviewed or modified, they […]
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe to a more stringent one. Compared to the MDD, the MDR promotes a life-cycle approach similar to what the US FDA and many international standards advocate. MDR highlights the importance of medical device risk management. Although risk management has […]
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 […]
Building Medical Software Compliance on Atlassian Tools
What is Atlassian Summit? The biggest annual event of Atlassian will take place next week with hundreds of Atlassian users and developers descending to San Jose to listen to the success story of one of the fastest growing enterprise software technologies today. Their high-velocity distribution model drives an exceptional customer scale by making affordable products […]
Building regulatory compliance into the software development life cycle
Safety is the central concern for medical device software development and the development of safe systems is rigorously supported by various regulatory requirements focusing on development process compliance. In other words, a strong emphasis is placed on regulatory oversight and device approval before market release to ensure proper verification and validation of these devices. Due […]
The worlds of software development and medical devices could not be further apart
Software development is agile, fast and innovative, while medical device development is often slow, reactive and change adverse. SoftComply has developed a set of tools which will help your company comply with the regulatory requirements with the minimum effort and get your innovative medical devices to market faster. Numerous software companies struggle to enter medical […]