We are happy to inform you that our Risk Management solution for Jira has gotten an upgrade for Jira Server users – the SoftComply Risk Manager Plus focusing specifically on safety-critical product/device/system risks. SoftComply Risk Manager Plus supports both Hazard Analysis as well as FME(C)A, including FME(C)A with Detectability and RPN (Risk Prioritization Number). Although […]
The Importance of IEC 62304 Compliance Part 2
Following up on our first blog post on how to become a trusted software supplier to established medical device manufacturers with the help of IEC 62304, we will now shed some light on specific clauses and requirements of that standard. IEC 62304:2006/Amd 1:2015, 4.3 – Software Safety Classification The 2015 amendment provides more clarity on […]
Manual Versioning of Risks with SoftComply Risk Manager
For tracking changes in risk management over time you might want to have versioning of your risk management table and risk reports. In other words, you may want to take a snapshot of the current status of your risks for an audit, archive that status and continue managing these risks in real time. Below is […]
The Importance of IEC 62304 Compliance
IEC 62304 outlines the guiding principles for the development of medical software. It is the gold standards for medical device companies, but its importance goes beyond legal manufacturers and established medical software suppliers. In the vast majority of cases, software embedded in a device (or a device itself) use abundant OTS (Off The Shelf) code, […]
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 […]