Table 3 Verification in practice.

From: Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs)

Documentation you can expect

Manufacturer should provide evidence of their BioMeT’s:

• Performance specifications for the integrated hardware

• Output data specifications

• Overview of software system tests

• Limitations to the verification testing

• e.g., specific known items that were not tested during verification

Clinical users’ questions answered by verification

Is the performance of this BioMeT and each of its components sufficient to generate sample-level data of acceptable quality such that it can be used as an input to generate the processed data and downstream clinical measurement that I am interested in?

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