Module 14: Design Development and Certification of Medical Devices

17/11/2023

REGULATORY STATUS ● Compliance with approved standards – For example pharmacopoeial grade polyolefins ● Materials containing “problem” ingredients – Safety concerns = HSE related factors – [Most recently in pharmaceutical packaging – nitrosamines..] ● Environmental factors – Disposal and waste management – Recycling – Transport and disposal of waste materials FACTORS INFLUENCING CHOICE OF MATERIALS

Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

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Masterclass: Lecture 3

The Organisation for Professionals in Regulatory Affairs

20

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