The Association for the Advancement of Medical Instrumentation (AAMI) will offer a webinar on "Current Issues in Medical Device Risk Management" on Aug. 14, 2014 from 11 a.m. to 12:30 p.m. ET.
With the increasing complexity of medical devices, device product recalls, and the growth of adverse events, manufacturers are facing the ever increasing challenge of making sure that a stringent process is in place for medical device risk assessment. This webinar will review the risk management principles shown in ANSI/AAMI/ISO 14971 standard. Register for this webinar and learn about the FDA risk management expectations for product submissions, review the FDA indicators of risk management shortcomings, and compare the FDA risk requirements to Europe’s expectations in the medical product directives. The information presented in this webinar will help you recognize the value of underused risk analysis tools.
This webinar is targeted to quality assurance and regulatory affairs personnel, design and process engineers, manufacturing and operations managers, and members of research and development or new product development teams.
Speakers are Edwin Bills, principal consultant with ELB Consulting, LLC, and Lorie Erikson, MT(ASCP), MSRA, consumer safety officer in the Division of Manufacturing and Quality at the FDA.
The cost is $315 per registration for AAMI members and $415 per registration for non-members.
To register, call 1-800-373-3174 or +1-240-646-7031 to order with a credit card, or regiaster online by clicking here.