Device Engineering, ISO 20072
Innovation, Engineering, Risk Assessment, Verification
Cambridge Medtech Solutions engineers have decades of experience in the design, development, industrialisation and verification testing of inhalers, encompassing DPI’s, pMDI’s and breath actuated mechanisms.
We are currently providing engineering support to clients developing inhalers, and our work is consistent with ISO 20072, ISO 13485, EU and FDA guidelines.
ISO 20072 covers the verification requirements and test methods for the majority of inhalers, which it refers to as ADDDs (aerosol drug delivery devices).
A key element of ISO 20072 is to establish the DFP (device functionality profile) which describes the key functional aspects of the device, and the acceptance limits. The definition of the DFP is typically driven by the Product Requirements Specification and the Risk Assessment.