Module 14: Design Development and Certification of Medical Devices

17/11/2023

FACTORS INFLUENCING CHOICE OF MATERIALS

DESIGN FLEXIBILITY… RHEOLOGICAL PROPERTIES ● Particularly during manufacture: – Melt temperature – Viscosity – Shrinkage – Component stability ● …and for medical device formulations

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

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FACTORS INFLUENCING CHOICE OF MATERIALS

BIOCOMPATIBILITY (ISO 10993) ● Potential effects in relation to use: – Long or short term – Implantability – Skin contact – Leachables and extractables – Interaction when co-administered with medicines

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

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