Software Risk Analysis in Medical Devices
In the Medical Device industry software components, whether standalone or as part of a physical device,…
Risk Management of Off-The-Shelf (OTS) Software
Your software is likely to contain a number of components, items, packages, libraries, etc. not developed…
Hazard Analysis and FMEA: the Most Common Approaches to Risk Management for Medical Devices
What is the difference between Hazard Analysis and FMEA. Which approach should you use. Comparison and examples.
4 Key Reasons Why you should move y for Risk Management in Jira
Risk management in the regulated industries is often viewed as a necessary evil, but what if…
4 Steps to ISO 27001 Compliance – Start with Risk Management in Jira
Being an ISO 27001-compliant company means that you protect your information assets and client data against…
3 Simple Steps to Prioritising your Critical Risks
“It’s a dangerous business, Frodo, going out your door. You step onto the road, and if…
Risks? We don’t have any… 6 Steps to Identify Organisational Risks
More often than not, Risk Managers confess to us that when they ask their colleagues about…
Managing Documents in the 21st Century
INTRODUCTION Although paper records still have their place in the modern industry, most companies use one…
Why Should Validation Work Silently in the Background?
Validation of software tools often leads to significant confusion as regulations mandate it but companies are…
AI in Medical Devices
The availability of AI on the web has not materialized like the murderous SkyNet from the…
Demystifying Software Tool Validation
Ever wondered why software tool validation is crucial in the medical device industry? With modern medical…
Don’t Leave Your Quality Team Behind!
Your Development team might find the instructions from Quality and Compliance team time-consuming – slowing down…