Our December Ask Me Anything with Milan Kuveljic on the topic of Testing in Compliance and Regulation took place tonight. As always with these events, there was a lot of questions on the night.
If we didn’t get to your question of you’re catching up on the Dojo and have thought of some questions you’d like to ask, please share them here.
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The first question related to one that was asked here on the Club a while ago
Prompted by this tweet from Jean Ann Harrison
Based on my own experience so far in FDA regulated companies it is really difficult to have agile practices in those environments. Equally waterfall based approaches can end up costing a lot of money when they fail at the end of the process. I’ve worked on a project where it was waterfall based and the deadline was forever being pushed later and later due to complications that could not have been foreseen. More recently I worked on a project whe…
A question that would be great for the community to elaborate on some more as Milan didn’t have direct experience in medical device regulation
What type/approach of quality assurance should apply to MDR (Medical Device Regulations) compliant software?
The question we didn’t get to although we did discuss access to production logs so perhaps this has already answered the question?
Is it possible to get telemetry data or usage metrics from production to help with development, testing and business decisions?
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