Usability Evaluation
Standard Summative
Meet ISO 11607 Section 7 requirements with a templated approach.
Custom Summative Usability Evaluation
Custom Summative Usability Evaluations use a custom plan to meet ISO 11607 Section 7 sterile packaging validation requirements. With the custom plan, medical device manufacturers (MDMs) may add to the scope of the study to receive feedback on labels, IFUs, etc.
Who is Custom Summative Usability Evaluation for?
Custom Usability Evaluations are for packaging engineering teams who want to comply with ISO 11607 and are looking for additional scope outside ISO 11607.
What's Included in a Custom Summative Usability Evaluation?
Meets ISO 11607 Section 7 Requirements
Fully custom project plan
Schedule your evaluation when it works for you
Ability to test multiple packaging configurations
15 End Users
Photography of aseptic presentation techniques for clients’ products
Video and audio recording of the entire process of the study
Technical immersion session to document device and packaging system to develop technical questions and acceptance criteria for study
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
Formative
Prior to usability evaluation, performing a formative study may be helpful in gaining feedback before a design freeze.