We are happy to announce Sterigenics will be exhibiting with our sister company Nelson Labs and Regulatory Compliance Associates at the MD&M West 2024 tradeshow in Anaheim California. From February 6th-8th, 2024 stop by our booth #3135 to speak to a member of our team. For more information, please visit: https://www.imengineeringwest.com
Please plan on joining us at the Med Tech Theater to hear from our dynamic industry-leading experts.
Tuesday February 6th, 2024. 1:30-2:15pm
Presenter: Helin Räägel, PhD, Biocompatibility Expert, – Nelson Labs
Biocompatibility as a Critical Design Input
Biocompatibility evaluation must accompany any medical device that has contact with a patient during use and is a requirement before a device can be cleared for market. This is usually the last step in device development and should be performed per ISO 10993-1. While biocompatibility should be assessed using the final finished device, it should not be considered as an after-thought, but instead be an active component of the design process. This presentation provides an overview of what biocompatibility is, and what should be considered when performing a biological evaluation. We will also discuss the importance of choosing the appropriate materials from the beginning of the design phase to addressing potential changes caused by supply chain issues.
Tuesday February 6th, 2024. 2:30-3:15pm
Presenter: Gregory Grams Technical Director, EO EMEAA, – Sterigenics
The Impact of Sterilization Modality on Connected Devices with Electronic Components
The connected device market is an emergent field in medicine. These technologies have delivered improvements in treatment outcomes and the patient experience across many market segments. The terminal sterilization of connected devices can present several unique challenges in comparison with standard non-connected devices. Their complex nature and combination of materials and electronic components can lead to malfunctioning devices. To help address these challenges, manufacturers of the connected devices must consider terminal sterilization during the initial design phase and develop a partnership with a sterilization provider to select the most suitable sterilization modality.