SoftComply
FME(C)A or FMEA?
FMEA or FMECA? Criticality or not? Which one is better? Which one should you use? The…
SoftComply
What is a Risk/Benefit Analysis & How To Do It?
The Risk / Benefit analysis is one of the most misinterpreted areas of the Risk Management…
What is FMEA and how is it different from Hazard Analysis?
From ISO 14971: “FMEA is a technique by which the consequences of an individual fault mode…
SoftComply
New Medical Devices Regulation & Risk Management
The revised Medical Devices Regulation (MDR) will change the regulatory environment of medical devices in Europe…
SoftComply
What is FMEA and when to use RPN?
Per ISO 14971, “Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis…
SoftComply
How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA
Part II By Matteo Gubellini, VP of Regulatory Affairs at SoftComply* So you are looking for…
SoftComply
How I came to hate Excel & decided to develop an automated Risk Management tool for JIRA
Part I By Matteo Gubellini, VP of Regulatory Affairs of SoftComply* “Ok, let’s follow a few…
SoftComply
Cloud-Based SaaS Tools & Software Validation Compliant with Medical Device Regulations
The continued rise in the use of cloud-based and SaaS (software as a service) tools adds…