ISO 14708-5 Implants for surgery - AIMD_ Clause 6.3.1 Evidence Mapping

cobedangthuong

Registered
Hello Everyone,

Can anyone guide me which document/evidence should be mapped to demonstrate compliance to clause 6.3.1 of ISO 14708-5 ?
Is the verification/validation report pertinent to be mapped?

"A comprehensive analysis shall be performed for the integrated system, the various component configurations, as well as for each system component for all safety and effectiveness issues, such as tolerance stack-up analysis, and structural analysis."

Much appreciated for any help!
 
Top Bottom