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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
Read before Buy!
Is the Usability engineering file template developed as per latest version of EN / IEC 62366-1 standard?
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?
Refund Policy
How to download Invoice
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?
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Template 1 is used when the manufacturer is implementing Usability engineering aspects during the initial D&D phase of the device.
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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.
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 |
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Usability Engineering File (UOUP) : 250 USD Template ID: I3C-UEP-02 |