Module 15 2022

19/05/2022

Clinical Evaluation – Article 61 (10)

Example of a device suitable for article 61.10 Washer Disinfector for surgical instruments ● No contact or interaction with patients ● Not intended to treat or diagnose patients ● State of the art – clinical studies not carried out ● Product standards available ● Risks to patient can be addressed by bench testing/validation ● Risks to user can be evaluated through usability studies  I can meet each GSPR with non clinical data

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

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