Software license key regulatory requirements

#1
Hi,

Does anyone have experience in making a license key available for the customer to access additional functionality of a medical device software (product has a hw - not SaMD), including how it is made available to the customer (license? product code? etc), installation and requirements regulatory (CE, FDA, Anvisa)?
I understand that regulatory approval must be performed considering the complete software, but how to relate regulatory approval (which may be requested by the customer) of the complete software, mentioned in the technical documentation, with the license code or with the code of the "product" sold (additional functionality)?

Thank you in advance! :)
 
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Ronen E

Problem Solver
Moderator
#2
My initial thought is manage it as 2 variants of the same device - a basic variant and an enhanced one. Bundle both in the same regulatory submission and clearance - you will have 2 sub-models cleared. I feel that from a regulatory perspective it matters less whether the upgrade is HW or SW and how you implement it; in essence it's a given device, that upon certain actions can be transformed into another. Both are cleared so there shouldn't be a regulatory problem.
 

Junn1992

Quite Involved in Discussions
#3
I would also look out for risks that additional functionality can be "unlocked" without the key provided, and how it affects device usage, patient safety etc.
 
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