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 […]
What is FMEA?
FMEA stands for Failure Modes and Effects Analysis, it is a step-by-step approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode are systematically identified and evaluated. It is an […]
Hazard Analysis & FME(C)A on Jira – SoftComply Risk Manager PLUS is out now!
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 […]
Building a Self-driving Car or an Airplane? Get Risk Management Help from Medical Device Industry!
All businesses are familiar with risk management, be it strategic business risks, financial risks, project risks, products risks or any combination of these that they are managing. Most product development projects include managing product risks to ensure that the product works as envisioned within the range of acceptable risk. For safety-critical products such as cars, […]