AAMI Offers Webinar on Risk Management Terminology Best Practices and FDA's Perspective


The Association for the Advancement of Medical Instrumentation (AAMI) will offer a live webinar, "Risk Management Terminology: Best Practices and FDA’s Perspective," on Dec. 13, 2016, from 11 a.m. to 12:30 p.m. ET.

Medical device risk management terms can be confusing in real-world practice. This webinar introduces industry best practices in the use of these terms and associated benefits to practitioners, independent reviewers, healthcare institutions, patient safety advocators, and ultimately patients.

With today's international regulatory environment and complex healthcare systems, more multidisciplinary professionals and stakeholders are involved in risk management, more devices are inter-connected, and the results of one risk analysis may become input to another risk analysis. Inconsistent use or misuse of risk management terminology can become a real challenge for engineering productivity, risk management effectiveness, stakeholder communications, and even regulatory compliance.

This webinar introduces industry best practices in the use of these terms and associated benefits to practitioners (e.g. engineers, regulatory compliance specialists, management), independent reviewers (e.g. FDA), healthcare institutions (and their IT and Biomedical staff), patient safety advocators, and ultimately patients. A representative from FDA's Center for Devices and Radiological Health will join the webinar to share FDA's perspective. A Q&A session will be provided at the end of webinar for attendees to ask questions.

Over the course of 90 minutes, the program will:
•Review commonly confused terms in risk management
•Introduce the Risk Analysis Taxonomy Method
•Teach best practices to resolve potential confusions
•Explain benefits to practitioners and stakeholders
•Share FDA's perspectives on risk management terminology
•Provide an opportunity to ask presenters questions

Trainers include Fubin Wu, co-founder of GessNet™ Risk Management Consulting; and Lt. Cmdr. Alan Stevens, branch chief of the General Hospital Devices Branch, ODE/CDRH, at the Food and Drug Administration.

The program is targeted to medical device, healthcare, and public health professionals involved in or concerned with medical device risk management, safety assurance, or regulatory compliance. Given the broad application of risk management, this webinar is extremely valuable to professionals working across the entire medical device lifecycle, including: R&D, QA, regulatory affairs, regulatory agencies or notified bodies, manufacturing, product support, healthcare system integration or delivery organizations. It will also appeal to FDA staff, and patient safety advocators interested in best practices in medical device risk management

The registration fee is $119 for AAMI members and $199 for non-members. To register,CLICK HERE.

Source: AAMI

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