April 18–19, 2018Boston Convention & Exhibition CenterBoston, MA

BIOMEDevice Boston 2018 Schedule Viewer

View, browse, and sort the education offerings, networking opportunities, and event activities by using the filters below; you can search by Pass Type, Free Content & Activities, and Conference Track. With this session scheduler, you can build your daily agenda in advance and access the full list of options during the event. Sessions do fill up and seating is first come/first serve, so please arrive early to sessions that you would like to attend.

Risk-Based Approach to Biocompatibility Strategy


Chris Parker, M.S, M.B.A. (Study Director and Associate Director, Toxikon)

Location: Tech Theater, Booth 155

Date: Thursday, April 19

Time: 11:30am - 12:15pm

Free Content & Activities: Tech Theater

Vault Recording: TBD


Evaluating all considerations of a testing program prior to initiation is both critical to success and a requirement of ISO-10993-1. ISO-10993 biocompatibility testing has increasingly become a risk based process with the requirements to understanding device intended use and material composition more and more of an interdependent relationship. Once an evaluation and test plan has been established and a device is ready for testing, a series of considerations related to ensuring the compatibility with a device with the various test systems should be performed. These considerations require an in-depth knowledge of your device and knowing the details to provide your biocompatibility lab can help assure accurate assessments and minimize interruptions to the testing schedule. Examples of these considerations include compatibility with the extraction vehicles and condition selected (material changes, degradation, discoloration etc.), rubber components in a device which is a positive control in cytotoxicity testing, and device size in relation to available vasculature for in-vivo thrombogenicity testing. Case studies of the test strategies and potential results of different devices will be presented.