Usability Evaluation
Formative
Prior to usability evaluation, performing a formative study may be helpful in gaining feedback before a design freeze.
Standard Summative Usability Evaluation
Standard Summative Usability Evaluations use a templated plan to meet ISO 11607 Section 7 sterile packaging validation requirements.
Who is Standard Summative Usability Evaluation for?
Engineering teams for medical device manufacturers who want to be compliant with ISO 11607 but are budget-constrained often rely on standard summative evaluations of usability.
What's Included in a Standard Summative Usability Evaluation?
Meets ISO 11607 Section 7 Requirements
Templated project plan
Standard evaluations occur once a quarter
One package tested only
15 end users
Photography of aseptic presentation techniques for clients’ products
Video and audio recording of the entire process of the study
Preliminary meeting about acceptance criteria for packaging
Clinical assessor profile(s)
Details of the use environment, gowning, and surgical suite simulation
Objective evidence that the three items required by ISO 11607-01:2019 have been evaluated
Protocol report
Let's Start Your Usability Evaluation
To get started on your usability evaluation, please provide your contact information and select an option that fits your needs or select 'I Need Guidance' if you require some assistance.
More Usability Evaluation Options
Usability Evaluation
Custom Summative
Custom Summative Usability Evaluations meet ISO 11607 sterile packaging validation requirements. The custom approach allows for additional feedback on labels, IFUs, and more.