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Usability Documentation

On the basis of your already existing research data, we create a usability engineering file (or human factors report) that is ready to provide all the necessary evidence that your product complies with the regulatory requirements concerning the usability of medical devices or IVDs.

Medical usability documentation according to IEC 62366-1 and FDA guidelines.

Usability Documentation

On the basis of your already existing research data, we create a usability engineering file (or human factors report) that is ready to provide all the necessary evidence that your product complies with the regulatory requirements concerning the usability of medical devices or IVDs.

Medical usability documentation according to IEC 62366-1 and FDA guidelines.
All usability documents for clearance

All usability documents for clearance

According to IEC 62366-1 and FDA Guidelines

According to IEC 62366-1
und FDA Guidelines

For the European market

For the
European market.

For the American market

For the
American market.

For medical devices and IVDs

For medical devices
and IVDs

All usability documents for clearance

All usability documents for clearance

According to IEC 62366-1 and FDA Guidelines

According to IEC 62366-1
und FDA Guidelines

For the European market

For the
European market.

For the American market

For the
American market.

For medical devices and IVDs

For medical devices
and IVDs

HOW DOES A DOCUMENTATION WORK WITH US?

Get an overview in the video.

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HOW DOES A DOCUMENTATION 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

Kick-off of an usability documentation project.

Kick-off:

Here we start with an identification of the current state of your documentation and get to know your goals and expectations.

01

Kick-off of an usability documentation project.

Kick-off:

Here we start with an identification of the current state of your documentation and get to know your goals and expectations.

02

Gap-Analysis:

Your previous documents are checked for completeness and correctness using checklists and templates. We find out for you which usability engineering activities and which documentations are still missing.

Gap-analysis of a usability documentation

02

Gap-analysis of a usability documentation

Gap-Analysis:

Your previous documents are checked for completeness and correctness using checklists and templates. We find out for you which usability engineering activities and which documentations are still missing.

03

Conducting missing usability activities such as a summative evaluation

Execution of missing usability activities:

From planning to preparation to execution and evaluation, the missing parts of the summative evaluation are now being completed by us (if necessary).

03

Conducting missing usability activities such as a summative evaluation

Execution of missing usability activities:

From planning to preparation to execution and evaluation, the missing parts of the summative evaluation are now being completed by us (if necessary).

04

Preparation of the usability documentation:

Based on the already performed usability activities and the existing usability documentation we create your usability engineering file or human factors validation report. From the completion of existing documentation, the post-documentation of usability activities or the complete creation from scratch – we help you to finalize your usability documentation.

Preparing and handing over the usability documentation

04

Preparing and handing over the usability documentation

Preparation of the usability documentation:

Based on the already performed usability activities and the existing usability documentation we create your usability engineering file or human factors validation report. From the completion of existing documentation, the post-documentation of usability activities or the complete creation from scratch – we help you to finalize your usability documentation.

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

For the execution of the missing usability activities, you can use our Medical Usability Lab. Here you have the possibility to attend the studies live on site or remotely.

Suitable camera equipment allows you to always have an overview of everything, both live and in the recordings. Our audio equipment also provides you with crystal-clear sound.

Our equipment

For the execution of the missing usability activities, you can use our Medical Usability Lab. Here you have the possibility to attend the studies live on site or remotely.

Suitable camera equipment allows you to always have an overview of everything, both live and in the recordings. Our audio equipment also provides you with crystal-clear sound.

What do you get?

  • If necessary, all required usability activities such as the summative evaluation as a basis for the documentation.

  • A complete usability engineering file or a complete human factors report and the resulting correctly documented data for the notified body or the FDA.

Usability Engineering File and Human Factors Validation Report

What do you get?

Usability Engineering File and Human Factors Validation Report
  • If necessary, all required usability activities such as the summative evaluation as a basis for the documentation.

  • A complete usability engineering file or a complete human factors report and the resulting correctly documented data for the notified body or the FDA.

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.