A new technical report, AAMI TIR59:2017, Integrating human factors into design controls, provides industry with detailed guidance on the integration of human factors and usability engineering into design controls, with use-safety as a primary objective of new device design and development. AAMI HE committee member Sean Hägen will provide an overview of the report, with a focus on the practical implementation of human factors engineering/usability engineering processes, activities and their corresponding applicability to a new or pre-existing quality system’s design controls in accordance with 21 CFR 820.30 as well as ANSI/AAMI/IEC 62366-1:2015.
Topics covered include:
- Importance of incorporating pre-design controls human factors engineering (HFE)/usability engineering (UE) processes
- The pros and cons of different HFE/UE process adoption approaches
- Who are the stakeholders in the HFE/UE process and implementation plan
- The relationship of the HFE/UE process to the Risk Management process
The webinar takeaways include:
- Understanding the expectation deltas between the FDA and IEC in context of a Design Controls process
- Understanding the need to assess the scale a HFE/UE process under design controls
- The relationship of the HFE/UE process with Design Inputs/Outputs and V&V
- Sean Hägen, IDSA, HFES, Principal, Director of Research & Synthesis, BlackHägen Design, Dunedin, FL
This webinar is designed for all developers and manufacturers of medical product systems and combination products that contain a device constituent part. The TIR is for those manufacturers intending to commercialize products in the United States and therefore does not address all requirements for commercializing products outside the U.S.
Registration Fee: $149 AAMI member / $249 List
Includes one connection on one computer at one physical location plus one-year access to the recording.