BIOCOMPATIBILITY AND EXTRACTABLES TESTING

A major medical device manufacturer needed to implement material changes to their product line with outdated regulatory files. Dellshire experts designed and provided biocompatibility (ISO 10993 Part 6) and extractables testing protocols written for the family of products. Procedures and processes were reviewed; studies were designed and monitored at contract laboratories that conducted the biocompatibility testing. A laboratory was contracted to complete extractables testing and materials evaluations. Dellshire reviewed and provided guidance on completion of the extractables protocols and draft reports from the analytical laboratory. This project provided the data and information needed to update the regulatory files for material change control and keep the products on the market.