Usability Evaluation
Standard Summative
Meet ISO 11607 Section 7 requirements with a templated approach.
Formative Usability Evaluation
Formative Evaluations are conducted at the design stage of packaging development and are used for competitive purposes (packaging types, size, etc.). While a Formative Evaluation does not meet the requirement of the FDA, these evaluations are a tool to reduce risk before a design freeze for the packaging system.
Who is Formative Usability Evaluation for?
R&D packaging teams for medical device manufacturers who want feedback to optimize packaging designs before the design freeze.
What's Included in a Formative Usability Evaluation?
Does not meet the ISO 11607 Section 7 Requirement - Used for feasibility purposes to gain confidence that packaging system will pass the formal usability evaluation
Six end users with PCL packaging engineers
Formalized discussion notes
Photos and panel recommendations
Objective evidence that the three items required by ISO 11607-01:2019 have been evaluated
Technical summary memo with completed evaluation
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
Meet ISO 11607 Section 7 requirements with a custom approach and gain insights on labeling, IFU's, and more.