The U.S. FDA released a new guidance document on wireless medical devices, “Radio Frequency Wireless Tehnology in Medical Devices”, on August 13, 2012. Its purpose is to address the growing use of wireless technology in medical devices in support of health care and new avenues for risk, such as signal interference / interruption.
FDA stated: “It is essential that manufacturers first consider and test potential limitation of the wireless connectivity associated with their devices to prevent manfunctions that could harm patients.”
This is a relatively new, but growing field. Our instructor, a renown industry expert, John E. Lincoln has regulatory experience in wireless devices and has prepared two such 510(k)s. He recently published a journal article on this new guidance. In this webinar he will also discuss the consideration of the FDA’s concerns over which device functions could be made wireless, and which should employ wired connectivity.
Areas to be Covered:
The Guidance focuses on two areas, as will this webinar:
Considerations for Design, Testing and Use of Wireless Medical Devices
Recommendations for Premarket Submissions for Devices that Incorporate RF Wireless Technology.
Security issues and electromagnetic compatibility (EMC).
The risk-based approach to verification and validation of such devices
Unique labeling requirements
Who will Benefit:
This webinar will provide valuable assistance to all regulated companies that are or anticipate having products in this growing market. Its principles apply to personnel / companies primarily in the Medical Devices fields. The employees who will benefit include:
QA / RA
All personnel involved in design, development, manufacture, verification and/or validation planning, execution and documentation for such devices