Usability Engineering: How the Updated ISO 14971:2019 Changes Your Process – Webinar Recording/Transcript
Usability Engineering: How the Updated ISO 14971:2019 Changes Your Process
The FDA receives about 100,000 medical device incident reports each year — with about one-third attributable to user error. Design-related failures have been the leading cause of device recalls, at 36%. You need to be clear on how to effectively implement the updated ISO 14971:2019 risk management standard regarding usability engineering.
One key ISO 14971:2019 update is that you need to consider and document reasonably foreseeable misuse errors — including abnormal use — in your risk assessment and risk management process. The process must go on to implement risk control measures, check that they work and ensure the user correctly perceives and understands the safety information.
During this presentation you’ll get details on the concepts, major definitions and a conceptual model to help you understand the approach. Examples will illustrate use error, show the relationship to the risk management standard and how it compares to European Union Medical Device Regulation (EU-MDR) and European Union In Vitro Diagnostic Regulation (EU-IVDR) requirements for usability.
- What you must know about the regulatory status of the standards in the U.S., EU and Canada
- How to make ISO 14971:2019 work for you
- How to stay complaint according to the FDA Center for Devices and Radiological Health’s (FDA-CDRH) approach to usability engineering
- How to comply with the EU-MDR and EU-IVDR requirements for usability engineering
- How to incorporate the concepts of formative and summative evaluation
- Which inputs you must add to your user interface specification
- What to include in terms of elements on your user interface evaluation plan
Ensure device compliance when you easily implement the updated ISO 14971:2019 risk management standard regarding usability engineering.
Meet Your Presenter
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Mr. O’Leary has more than 30 years’ experience in quality, operations and program management in regulated industries including medical devices and clinical laboratories. He has a Masters Degree in Mathematics; is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Who Will Benefit
- Design engineering managers
- Interface designers, including software engineers
- Technical writers providing instructions for users
- Usability engineers
- Risk managers
- Professionals involved in complaint management and MDR reporting