Element at CES: Product Safety Compliance for Medical Devices

Discover an informative in-booth presentation that focuses on how to navigate the complex landscape of medical device safety and necessitates understanding the standards and regulatory requirements of bodies such as the United States Food and Drug Administration (FDA).

Medical devices need to address differences between basic safety, essential performance and intended use. There are different requirements and standards for various functions, many of which need different types of testing. It can be challenging to navigate these complex requirements and to understand which requirements take precedence. This presentation is designed to help simplify this process.

Available to registered CES attendees only

Bob Burek is a Product Safety Technical Manager for Element Materials Technology’s Connected Technologies and Mobility business unit. He graduated from Northeastern University with a degree in Electrical Engineering and has over 30 years’ experience evaluating devices for Product Safety and regulatory compliance. Bob was the TIC Council Chairperson for The FDA Accreditation Scheme for Conformity Assessment (ASCA) program, and in various standard development panels for medical and related devices.  He is active the IECEE CB Scheme’s Expert Task Forces for Medical, Laboratory, and Information Technology Equipment.    

Host or Publisher Element Materials Technology