| |
|
|
|
Xtalks, Online
2024-04-24
Is a team designing a medical device and seeking guidance on electromagnetic compatibility regulatory requirements? Or is there a need to integrate a radio into the device, necessitating an understanding of Federal
Communications Commission (FCC) and The United States Food and Drug Administration (FDA) regulations? Would less regulatory pushback accelerate the time to market? Is there an interest in acquiring more knowledge and guidance for this process?
In this webinar, the expert speakers will discuss basic electromagnetic compatibility requirements under IEC 60601-1-2, the growing field of radio frequency identification (RFID) immunity, wireless coexistence and more.
Connected medical devices have additional challenges and requirements to meet before going to market. Radio regulations need to be addressed and a risk assessment is necessary to determine how the radio functions affect essential performance. In this webinar, the attendees will learn how ANSI C63.27 can be used to tackle the FDA’s interest in wireless coexistence and how AAMI TIR69 covers how to assess risks.
Medical devices also need to address differences between basic safety, essential performance and intended use. There are different requirements for various functions, many of which need different types of testing. It can be challenging to navigate these complex requirements and which requirements take precedence. This webinar is designed to help simplify this process.
Join this webinar to learn about electromagnetic compatibility for medical devices. The experts will cover best practices when integrating radios into a medical device, which will help create a path to ensure a smooth regulatory process. In the USA, medical devices need to meet both FCC and FDA requirements, and this webinar covers how to achieve this goal.
Keywords: Medical Device, Medical Devices, Regulatory, Medical Device Regulation, Medical Device Manufacturing, Medical Device Design, Medical Device Development
|
|
|
|
|
|
|
|
Organized by:
|
|
Xtalks |
|
|
Invited Speakers:
|
|
David Schaefer, EMC Technical Manager, Element Materials Technology
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
2024-04-24
|
|
|
|
|
|
|
|
Registration:
|
|
Free Registration
|
|
|
E-mail:
|
|
tristan@xtalks.com
|
|
|
|
|
|
|
|
|