BIOMEDevice San Jose is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

BIOMEDigital 2020 Session Viewer

Welcome to the BIOMEDigital session viewer. Browse and sort the growing list of sessions by day or track. All sessions are shown in Eastern Time.

Strategic Use of Predicate Controls in Biocompatibility Evaluations

Chris Parker  (Associate Department Head In-Vivo Biocompatibility, Toxikon)

Date: Thursday, November 5

Time: 10:00 am - 10:30 am

Track: Tech Theater

Vault Recording: TBD

Biocompatibility is no longer a checkbox approach and as the technology behind devices becomes more advanced, so too much the evaluations used to assess medical devices. The use of predicate controls in the biological evaluation of medical devices including biological evaluation plans, risk assessments and testing can help frame the context of a new device. In testing, the use of predicate controls in traditional evaluations including implantation and hemocompatibility, but also additional ones such as irritation and toxicity, can help normalize and clarify results to best understand the difference between positive and adverse results.

The Advanced Manufacturing Technology Series Asia • North America • South America Learn More »