Usability Engineering in Medical Devices.pdf

Usability Engineering for Medical Devices

1. Regulatory Perspectives:
Usability Engineering and Its
Significance in Medical Devices Design

2. What is Usability Engineering?
Usabilityengineeringisaprofessionaldisciplinethat
focusesonimprovingtheusabilityofinteractivesystems
IncaseofMedicalDevices,itreferstoDegreeof
SuitabilityofaMedicalDevice’sdesigntosupportits
intendeduse.

3. ThePrinciplesofUsabilityareappliedto:
DesignofProducts
AssessedduringR&D-dFMEA
DesignofProcesses
AssessedduringProcessDesign- pFMEA
DesignofSystems
Ultimately,toreducehumanerrorandensure
safetyandcomfort-aFMEA

4. Human Factors:
Design, Engineering & Psychology Considerations
IntersectionofDesign,Engineeringand
Psychologyformsthehumanfactors,
whichdefinetheuserexperiencein
termsofSafety,UsabilityandComfort

6. Usability Engineering: Relevant Regulations
21 CFR Part 820.30 (QualitySystem Regulations for Devices, DesignControl –(g)
DesignValidation
Medical Device Regulation(MDR) 2007/47/EC
3 amended in2010
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Gui
danceDocuments/ucm070642.pdf
https://eur-lex.europa.eu/legal-content/en/TXT/?uri=CELEX:32007L0047
http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/2006/Preventing-Medication- Errors-
Quality-Chasm-Series/medicationerrorsnew.ashx

7. Its Important to Consider the Differences in Order to Evaluate
Usability
Handle too small for one may be too big for another!

8. Thanks for reading!
Learning never stops at
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