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Summative Evaluation / Human Factors Validation

You want to conduct a summative evaluation / human factors validation for your medical device or IVD according to IEC 62366-1 and FDA Guidelines? We support you! From the recruitment of participants to the successful execution, you are in safe hands with us.

Summative Evaluation / Human Factors Validation

Summative Evaluation / Human Factors Validation

You want to conduct a summative evaluation / human factors validation for your medical device or IVD according to IEC 62366-1 and FDA Guidelines? We support you! From the recruitment of participants to the successful execution, you are in safe hands with us.

Summative Evaluation / Human Factors Validation
Recruitment of suitable users

Recruitment of
suitable users

Complete organization and execution

Complete organization
and execution

Freely configurable Usability Labs

Freely configurable
Usability Labs

CE and FDA incl. documentation

CE and FDA
incl. documentation

For medical devices and IVDs

For medical devices
and IVDs

Recruitment of suitable users

Recruitment of
suitable users

Complete organization and execution

Complete organization
and execution

Freely configurable Usability Labs

Freely configurable
Usability Labs

CE and FDA incl. documentation

CE and FDA
incl. documentation

For medical devices and IVDs

For medical devices
and IVDs

HOW DOES A SUMMATIVE EVALUATION / HUMAN FACTORS VALIDATION WORK WITH US?

Get an overview in the video.

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HOW DOES A SUMMATIVE EVALUATION / HUMAN FACTORS VALIDATION WORK WITH US?

Get an overview in the video.

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This is what a cooperation with us looks like

This is what a cooperation with us looks like

01

Training of the participants for a summative evaluation / human factors validation

Kick-off:

In our kick-off, we plan the project together and make sure that all core questions and expectations are defined. Here we also get to know your product as well as your hazard-related use scenarios and risk analysis. Together we set a final schedule and make sure that the project runs exactly as you want it to.

01

Training of the participants for a summative evaluation / human factors validation

Kick-off:

In our kick-off, we plan the project together and make sure that all core questions and expectations are defined. Here we also get to know your product as well as your hazard-related use scenarios and risk analysis. Together we set a final schedule and make sure that the project runs exactly as you want it to.

02

Recruitment of participants:

We recruit the right participants for your study. Regardless of whether you need patients or health care professionals, we have access to a large database of users. We define the criteria for recruitment in consultation with you.

Recruitment of participants for a summative evaluation / human factors validation

02

Recruitment of participants for a summative evaluation / human factors validation

Recruitment of participants:

We recruit the right participants for your study. Regardless of whether you need patients or health care professionals, we have access to a large database of users. We define the criteria for recruitment in consultation with you.

03

Execution of the summative evaluation / human factors validation

Planning the summative evaluation:

We will take care of the complete planning of the summative evaluation / human factors validation for you. From the study guide to the preparation of the usability lab.

03

Execution of the summative evaluation / human factors validation

Planning the summative evaluation:

We will take care of the complete planning of the summative evaluation / human factors validation for you. From the study guide to the preparation of the usability lab.

04

If necessary – training of the users:

According to your instructions for use or your training material, we train the users for your study and also consider any decay time that may exist.

Training of users for a summative evaluation / human factors validation

04

Training of users for a summative evaluation / human factors validation

If necessary – training of the users:

According to your instructions for use or your training material, we train the users for your study and also consider any decay time that may exist.

05

Execution of the summative evaluation / human factors validation

Execution:

After an initial test, we collect your feedback to integrate adjustments to the process and then test with the remaining participants. This way, we make sure that the execution goes according to your wishes. You are also welcome to attend live – on-site or remotely.

05

Execution of the summative evaluation / human factors validation

Execution:

After an initial test, we collect your feedback to integrate adjustments to the process and then test with the remaining participants. This way, we make sure that the execution goes according to your wishes. You are also welcome to attend live – on-site or remotely.

06

Analysis & documentation:

We analyse the summative evaluation / human factors validation for you. You will receive all results of your summative evaluation as a written report. The Root Cause Analysis is included here!

Evaluation and documentation of the summative evaluation / human factors validation

06

Evaluation and documentation of the summative evaluation / human factors validation

Analysis & documentation:

We analyse the summative evaluation / human factors validation for you. You will receive all results of your summative evaluation as a written report. The Root Cause Analysis is included here!

07

Presentation of results of the summative evaluation / human factors validation

Presentation of results:

At the end of the project, we present the results to you in a compiled form and hand over all documents to you.

07

Presentation of results of the summative evaluation / human factors validation

Presentation of results:

At the end of the project, we present the results to you in a compiled form and hand over all documents to you.

Do you have questions?

You would like to discuss your specific case with us?
Contact us and book your free appointment.

Do you have questions?

You would like to discuss your specific case with us?
Contact us and book your free appointment.

Our equipment

In our UX-Medical labs, any use environment can be easily simulated. High-end equipment (such as a patient simulator or a complete configurable operating room) is available to you here. We offer high-resolution cameras for livestreams and recordings of the execution.

Our equipment

In our UX-Medical labs, any use environment can be easily simulated. High-end equipment (such as a patient simulator or a complete configurable operating room) is available to you here. We offer high-resolution cameras for livestreams and recordings of the execution.

What do you get?

  • A methodically clean set-up for your summative evaluation / human factors validation

  • A professional recruitment of the users.

  • If necessary: A training of all participating users conducted by us.

  • Several usability and user experience labs, including patient simulator and high-end equipment for recording and test execution.

  • The execution of the summative evaluation / human factors validation.

  • Results in the form of a written report

  • If desired, a separate highlight video.

Usability Engineering File and Human Factors Validation Report

What do you get?

Usability Engineering File and Human Factors Validation Report
  • A methodically clean set-up for your summative evaluation / human factors validation

  • A professional recruitment of the users.

  • If necessary: A training of all participating users conducted by us.

  • Several usability and user experience labs, including patient simulator and high-end equipment for recording and test execution.

  • The execution of the summative evaluation / human factors validation.

  • Results in the form of a written report

  • If desired, a separate highlight video.

LET US BEGIN!

Do you want to work together quickly, purposefully and pragmatically? Get in touch and we’ll find out together how we can support you.

Do you want to work together quickly, purposefully and pragmatically? Get in touch and we’ll find out together how we can support you.