Hello,
When we place a class 2 IVD in clinical performance study, it should be safe and representative of the "final" configuration.
Also, the assembly processes qualified for the study must be equivalent to the processes used to support the commercialisation launch.
Now, limiting focus to EU and US regulatory requirements:
Which is the industry practice in term of the related assembly line qualification? and, which is the minimum requirement by the regulators?
Example: can clinical study devices be assembles manually, when it is supposed to have an automated line for mass production?
Thank you,
Cate
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Caterina Puddu
Malmesbury
United Kingdom
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