Overview
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.
Webinar Takeaway
- 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:
- Senior management
- Middle management
- R&D
- Engineering
- Software
- QA / RA
- Manufacturing
- Operations
- Consultants
- cGMP instructors
- All personnel involved in design, development, manufacture, verification and/or validation planning, execution and documentation for such devices
Faculty John E. Lincoln
Medical Devices / Regulatory Consultant; also pharma and dietary supplements
Saint George, Utah
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
1.5 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 1. 5 credits towards a participant's RAC recertification upon full completion.
World Compliance Seminars (WCS) is a Regulatory Affairs Professional Society (RAPS) RA Professional Development Portal provider. World Compliance Seminars is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs. World Compliance Seminars has agreed to follow RAPS-established operational and educational criteria
