Tag Archives: ASM Medical Material database™

How Cook Medical’s regulatory team uses materials data

How Cook Medical’s regulatory team uses materials data

 

This week, I presented in a collaborative webinar with Cook Medical’s David Chadwick, Director of Regulatory Affairs, covering the best practise when applying materials data and predicate device information in healthcare. The healthcare industry faces a colossal task when choosing materials for use in new or existing medical devices. For those unfamiliar with the medical industry, the number of factors which need to be carefully considered when selecting a material for use in the human body can seem overwhelming; engineering properties, biocompatibility, effect of sterilization treatments, material-drug interactions, regulatory approval processes such as FDA approval and CE Marking, just to name a few. Continue reading