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Usability Validation Testing

introduction

This is one of our most important service provisions. To verify continually and then validate a medical device/system design is paramount. We can also offer this service for your devices developed in-house by your own teams. We also provide retrospective validation support services.

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Usability validation testing

Usability Test Protocol

 

Movement will define the test protocol, produced in close liaison with the client. This test protocol will include:

  1. Selection criteria for the end user groups, gender, age, anthropometrics, socio-economic background, number off.
  2. Test objectives and acceptance criteria.
  3. Specific instructions for the user groups.
  4. Product presentation inc. packaging & IFU.
  5. The testing environment for contextual appropriateness.
  6. The recording methodology of the tests.
  7. Number of researchers and their roles.

Usability validation testing

Test Logistics

 

Movement will handle all the logistics related to the required tests. This will include: the sourcing and recruitment of the participants, the hiring and setup of the location, NDA agreements and waivers, management and handling staff and also any catering needs that may be required.

Usability validation testing

Usability Engineering Study

 

The purpose of a usability engineering study is to verify, through functional testing, that a specific function is performing to specification. Many aspects of such studies are to verify safety parameters of specific elements/components of the design.

Movement design and conduct these tests in-house and produce the findings report which are referred to in the Usability Engineering File (UEF).

Usability validation testing

Formative Verification Tests

 

Prototypes will be tested with various users from the target market group. Movement will draw up the testing protocols to control the environment and context of the test conditions. Members of the Movement research team will be present to record. A verification test report will be generated with the raw findings and this will be issued to the client. Recommendations will be drawn up and used by Movement and our clients as the revised design inputs for further prototype specification. It is envisaged that these refinements will iron out concerns and issues discovered during this formative testing.

Usability validation testing

Summative Validation Tests

 

Production samples of the device will be tested in a lab space with the participants. Movement advise that a minimum of 20 participants from the user groups be involved. Past failure modes will also be assessed and validated. A report will be generated with the key findings and this can be submitted to the FDA as part of our client’s Human Factors Engineering Report, which is effectively a summary of your extensive Human Factors activities that will be ISO/IEC 62366 compliant. The Movement team will advise on final changes to the design specification prior to submission for CE marking & FDA approval.

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