Module 14: Design Development and Certification of Medical Devices

17/11/2023

Verification / Validation

The Organisation for Professionals in Regulatory Affairs

25

Verification / Validation

User Need “New drug ‘X’ needs to be delivered via autoinjector”

User Req. 1.3 “The drug should be delivered into intramuscular tissue”

Clinical Study

Activation into air

Functional Req. 1.1.1 “The extended needle length shall be 20mm” (User Req. 1.3)

Functional Req. 1.1.2 “No drug shall be delivered from the needle until the tip has reached a maximum depth of 15mm” (User Req. 1.3)

Validation

Verification

The Organisation for Professionals in Regulatory Affairs

26

13