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I've been tasked to develop a process for beta testing FDA regulated medical device software as part of design validation. The software is Class I.
Scenario: the software would be installed at a healthcare facility in a pre-agreed upon, limited, controlled way, and would NOT to be used for patient care. The goal would be to evaluate the behavior/performance of the software in scenarios where we can't realistically simulate all the subtleties of an actual facility's IT system.
I'm trying to work out if the above would mean that the software would be treated as nonconforming product or not (21 CFR 820.90).
I feel like I'm asking a "duh" question but I am having trouble putting together the pieces on my own. Any feedback would be much appreciated.
Scenario: the software would be installed at a healthcare facility in a pre-agreed upon, limited, controlled way, and would NOT to be used for patient care. The goal would be to evaluate the behavior/performance of the software in scenarios where we can't realistically simulate all the subtleties of an actual facility's IT system.
I'm trying to work out if the above would mean that the software would be treated as nonconforming product or not (21 CFR 820.90).
I feel like I'm asking a "duh" question but I am having trouble putting together the pieces on my own. Any feedback would be much appreciated.