I agree that it is important to have a good plan of how to handle testing failures when doing your V&V, but I like the points that @gh56, @merzkrashed, and @Sanam brought up, about spending more time on coming up with a reasonable and appropriate value for the acceptance criteria to reduce the risk of having failures during V&V. This definitely…[Read more]

hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what information is considered confidential (definitions and boundaries), obligations/responsibilities or what might considered a breach and lastly, as you have mentioned: time periods. A time period is…[Read more]

I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”.
When determining risk, the FDA assessing the severity, type, frequency, and length of harmful events. In addition, the FDA will also evaluate other…[Read more]

It was interesting to learn as @merzkrashed mentioned that the medical devices in India are largely unregulated. I came across this article/document which mentions that this is the case due to lack of medical device specific legislation on specifying standards of safety and quality for most medical devices. However this expected to change with the…[Read more]