Showing posts tagged with: ISO 14971
How to Apply AI Risk Prompts to Real-World Medical Device Development
Effective risk assessment is a foundation of compliant and safe medical device development. If you’ve downloaded our free guide with expert-level ChatGPT prompts, you've already made a strategic move toward improving your risk management processes.
Now it's time to translate those AI-generated insights into practical, real-world actions — grounded in standards like ISO 14971, IEC 60601,...
Cup of Joe 43# - Treat the cause, not the symptom
What is the root cause analysis?
Root Cause Analysis is something that we all do when we want to solve a problem for good.
But what RCA actually means?
It means to find what caused the problem, to find out not only what went wrong in the beginning, but how, when and why as well.
Basically, RCA is...
Risk as synonymous with uncertainty?
” Risk /rɪsk/, noun
the possibility that something unpleasant or unwelcome will happen.
Synonyms: chance, uncertainty, unpredictability, instability, riskiness…”
We’re dealing with countless risks in our daily life, like getting cut during apple slicing, or catching a cold if we get wet on a rainy day…or planning a project without a proper risk management plan…
Unknowingly you are doing...