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Human Factors Standards and Guidance's for Medical Devices - which documents apply to my situation?
This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device.
AAMI, IEC, and the FDA have produced several important standards and guidance’s over the past decade that pertain to the user interface design and usability testing of medical devices. Choosing the right one for reference and/or helping to ensure a compliant process can be a daunting task. In this seminar, we will review the existing standards for Human Factors and Usability, including the newly published HE-75 by AAMI entitled: Human Factors for Medical Devices, a set of best practices that brings a far sharper focus and application of human factors to medical device development than ever before. Participants will learn which standards and FDA guidance’s are currently being used by evaluators and how to apply them in various design situations.
Areas Covered in the seminar:
- Which standards apply to design vs. process for human factors?
- How the FDA and regulatory bodies apply the standards in evaluating submissions.
- Differences between "standards" and "guidances".
- Brief review of the content and coverage of the new standard, HE75.
- Where overlap exists between IEC terminology and AAMI terminology.
Who will benefit:
This webinar will apply to manufacturers with devices that require user-device interactions to set-up, operate, and maintain the device. Focus is on understanding the content and applicability to standards and guidance’s for Human Factors and Usability Engineering principles, including design best practices and an overall process for applying methods. Job functions that will benefit include:
- Research and Development functions: software, mechanical, industrial design, systems engineering
- Regulatory and Compliance: understanding how FDA and other notified bodies use these standards
- Risk Management teams
Robert A. North, PhD, is Chief Scientist of Human Centered Strategies, LLC specializing in creating strategies for applying Human Factors methods to medical device risk management and overall device effectiveness for several major manufacturers. Bob has worked as consultant to FDA/CDRH on analysis methods for use errors in adverse events, and is a member of the AAMI Human Factors Standards Committee currently developing a new standard for best practices. He has also recently served as faculty for Advamed (MTLI) in recent Design Controls seminars representing the FDA position on human factors. He is author or co-author on several articles appearing in MDDI's Device Link (on-line) and is on the faculty of the Regulatory Affairs Professional Society's (RAPS) 2008 Horizons Conference, presenting seminars on use error risk management strategies.
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Robert A North
Addressing the Elusive Use Error: Meeting Regulatory Expectations for Identifying and Controlling Medical Device Use-Related Hazards Tracking Use Error Risks in Post-Market Surveillance and CAPA Activities Applying Human Factors Best Practices for Medical Device Risk Management Pre-Market Submission Implications of FDA’s Human Factors Guidance and Device Priority List