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Formative Evaluation

You want to conduct a formative evaluation 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 implementation, you are in safe hands with us.

Formative Evaluation

Formative Evaluation

You want to conduct a formative evaluation 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 implementation, you are in safe hands with us.

Formative Evaluation
Recruitment of suitable users for the formative evaluation

Recruitment of suitable participants

Complete organization and execution of the formative evaluation

Complete organization
and execution

Freely configurable usability labs for formative evaluations

Freely configurable Usability Labs

Find and avoid critical use errors of your product early on with formative evaluations

Find critical use errors
of your product early on and avoid them

For medical devices and IVDs

For medical devices and IVDs

Recruitment of suitable users for the formative evaluation

Recruitment of suitable participants

Complete organization and execution of the formative evaluation

Organization and execution

Freely configurable usability labs for formative evaluations

Freely configurable usability labs

Find and avoid critical use errors of your product early on with formative evaluations

Find and avoid critical use errors of your product at an early stage

For medical devices and IVDs

For medical devices and IVDs

How does a formative Evaluation work with us?

Have a look into our video for a first overview.

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How does a formative Evaluation work with us?

Have a look into our video for a first overview.

Vimeo

We need your consent to load Vimeo videos. By loading the video, you accept Vimeo's privacy policy.
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This is what a cooperation with us looks like

This is what a cooperation with us looks like

01

Kick-off for a formative evaluation

Kick-off:

In a joint kick-off meeting, we will define the goals you want to achieve and collect all project-relevant information. We also develop a study guideline together.

01

Kick-off for a formative evaluation

Kick-off:

In a joint kick-off meeting, we will define the goals you want to achieve and collect all project-relevant information. We also develop a study guideline together.

02

Recruitment of participants:

We recruit the right participants for your study. In doing so, we draw on our large user database, which covers all user groups from lay to expert users.

Recruitment of participants for a formative evaluation

02

Recruitment of participants for a formative evaluation

Recruitment of participants:

We recruit the right participants for your study. In doing so, we draw on our large user database, which covers all user groups from lay to expert users.

03

Planning the formative evaluation

Planning the formative evaluation:

We develop the study guide for you and prepare our Medical Usability Lab accordingly.

03

Planning the formative evaluation

Planning the formative evaluation:

We develop the study guide for you and prepare our Medical Usability Lab accordingly.

04

Training of users (if necessary):

We train your users (if necessary) according to your instruction materials or your instructions for use. Of course, under consideration of the decay time.

Training of users for a formative evaluation

04

Training of users for a formative evaluation

Training of users (if necessary):

We train your users (if necessary) according to your instruction materials or your instructions for use. Of course, under consideration of the decay time.

05

Execution of the formative evaluation

Execution:

After running an initial test, we get your feedback to integrate adjustments to the process. After that, we test with the rest of the users. You want to be there live? That’s also possible – on site or remotely.

05

Execution of the formative evaluation

Execution:

After running an initial test, we get your feedback to integrate adjustments to the process. After that, we test with the rest of the users. You want to be there live? That’s also possible – on site or remotely.

06

Analysis & documentation:

After formative testing, we consult with you to determine the focus of the analysis.

Analysis and documentation of the formative evaluation

06

Analysis and documentation of the formative evaluation

Analysis & documentation:

After formative testing, we consult with you to determine the focus of the analysis.

07

Presentation of results of the formative evaluation

Presentation of results:

You will receive a descriptive analysis of the results of the formative evaluation and if desired detailed design recommendation for improving your product. We then discuss further steps for your product development.

07

Presentation of results of the formative evaluation

Presentation of results:

You will receive a descriptive analysis of the results of the formative evaluation and if desired detailed design recommendation for improving your product. We then discuss further steps for your product development.

YOU HAVE QUESTIONS?

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

YOU HAVE QUESTIONS?

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

Our equipment

In our Medical Usability Lab, the use studies for your product can be perfectly simulated. The testing of surgical instruments, monitoring devices and wound care solutions are just a few examples.

Our equipment

In our Medical Usability Lab, the use studies for your product can be perfectly simulated. The testing of surgical instruments, monitoring devices and wound care solutions are just a few examples.

What do you get?

  • The methodically correct structure for your study

  • 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 simulators and high-end equipment for recording and testing

  • The execution of the formative evaluation

  • Design recommendations for your product based on the results

  • A derivation of the next steps based on the data

Descriptive analysis and design recommendations as a result of a formative evaluation.

What do you get?

Descriptive analysis and design recommendations as a result of a formative evaluation.
  • The methodically correct structure for your study

  • 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 simulators and high-end equipment for recording and testing

  • The execution of the formative evaluation

  • Design recommendations for your product based on the results

  • A derivation of the next steps based on the data

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.