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Usability Engineering File Template and Procedure

A team of experts, drawing upon their expertise, analyzed the MDR and IVDR requirements and developed a usability engineering file template suitable for medical devices and a select group of IVD manufacturers. Usability is deemed an integral part of technical documentation, and, without favorable conclusions or study reports from usability studies, the device should not be released to the market

PMCF Plan Template
Read before Buy!

Is the Usability engineering file template developed as per latest version of EN / IEC 62366-1 standard?

Yes, the Usability engineering file template are made as per current standard and requirements.

Benefits of buying the procedures and Record templates?

The UEF related procedure and templates fully adhere to the requirements EN 62366-1. By purchasing the ready-to-use word files, companies can save valuable time spent on comprehension and editing, enabling them to submit reports with greater efficiency.

Who benefits from templates?

These templates are not designed for the general public. This template is drafted for professionals working in R&D, Desig and Development, QA, RA, and technical experts engaged in any regulatory documentation or MDR technical documentation.

Refund Policy

Once the softcopy document has been submitted, we regret to inform you that we cannot proceed with issuing a refund. It is essential to carefully read “read before buy” section.

How to download Invoice

You will be provided an invoice by PayPal in the same dropbox folder. No separate or alternative invoice provided.

Is the purchased files auto downloadable?

The files you purchased will not be instantly downloaded. However, within 1-5 hours of receiving the payment confirmation (excluding Sundays, as they are holidays), you will receive an email. Please Ensure to check the email address provided during the purchase process.

The email will contain a Dropbox link through which you can access and download the purchased item.

What is the difference between 2 record templates? How to choose which one?

  1. Template 1 is used when the manufacturer is implementing Usability engineering aspects during the initial D&D phase of the device.

  2. UOUP template is used if the manufacturer has not implemented the Usability engineering process at all or the device was manufactured before the EN 62366-1 standard is established, or not implemented during its D&D phase.

PMCF Plan Template

Usability Engineering File Template (Procedure / SOP)

Usability Engineering Process : 150 USD

Procedure ID : I3C-UEP-01

Usability Engineering File Templates (Record Templates)

Usability Engineering File : 250 USD

Template ID: I3C-UEP-02

Usability Engineering File (UOUP) : 250 USD

Template ID: I3C-UEP-02