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Objective of risk assessment in various stages of software validation?

What is the objective of risk assessment in various stages of software validation?
A).is the objective should be complaiance towards regulatory requirement or
B).is the objective should be towards managing the possible situation of break down / interruption or
combination both.
Can any one pl explain with example

There really shouldn’t be any activity that is done for the sake of regulatory compliance (maybe other than submitting paperwork). All required activities have, at their root, a sound business practice.

Risk management is no different. You are constantly evaluating your product to determine if there is a risk to the operator. As design evolves, you need to reassess the risks to determine if new risks have been exposed or if assumptions about existing risks are no longer appropriate.

Consider an example where you build a device prototype and hand it off to a focus group of potential users for initial evaluation. To your shock, they use the device in ways that were never originally intended - ways that could potentially harm them. You would use this information to update your risk assessment - possibly driving design changes. Similarly, if you are doing in-house testing and one of your testers is harmed (or at least potentially harmed), you would re-evaluate the risks and react accordingly.