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Testing tool for AC 8265

Luluyin
Beginner
245 Views

Dear Intel, 

We are trying to get the RF Testing Tool for the Intel AC8265 wireless card to perform the WiFi compliance testing in a new developed device for FDA 510(k) approval.

 

Thank you very much for your help and best,
Louie

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7 Replies
Mike_Intel
Moderator
194 Views

Hello Luluyin,


Thank you for posting in Intel community Forum.


For me to further check this, please help provide the following details:


  1. Can you tell me more about this inquiry?
  2. Are you using this tool for certification?
  3. Why do you need to get this tool?


If you have questions, please let us know. Thank you.


Best regards,

Michael L.

Intel Customer Support Technician


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Luluyin
Beginner
190 Views

Hi Michael,

Thank you for your reply.

We are a medical device development company currently working on an AR surgical navigation system that utilizes the AC 8265 for image and data transmission.

For FDA and CE applications, RF certification is required. Therefore, we need to entrust an external laboratory (one accredited with ISO 17025) to conduct TX/RX-related tests, such as adjusting channels, modulation methods, bandwidth, and power parameters.

These tests require the use of an RF tool, which is why we hope to obtain the relevant tool.

 

Best regards,

Louie

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Mike_Intel
Moderator
156 Views

Hello Luluyin,


Thank you for the update.


I sent an e-mail to the e-mail address associated with your community profile regarding the information you are looking for, please check it out. 


If you have questions, please let us know. Thank you.


Best regards,

Michael L.

Intel Customer Support Technician


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Luluyin
Beginner
140 Views

Dear Michael L.,

Thank you for your response and for providing Dekra’s contact information.

I have already reached out to Cindy at Dekra, as well as Intel’s distributor in Taiwan. Unfortunately, I have not received any responses from either party. Additionally, Dekra mentioned that due to their partnership with Intel, they are unable to provide the DRTU tool.

Regrettably, I am still unable to resolve my issue. Is there any other way you could assist me in obtaining the necessary tool or information?

I would greatly appreciate any further guidance you can provide.

Best regards,

Louie

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Mike_Intel
Moderator
93 Views

Hello Luluyin,


Thank you for letting me know.


However, before we proceed. Let me clarify, you mentioned that there is no response from Dekra but they said they cannot provide the DRTU tool? Kindly help further elaborate this for documentation for me to further assist you with the DRTU tool request.


If you can also provide more information on why you need this tool, that would help me in checking this with our Engineering team.


If you have questions, please let us know. Thank you.


Best regards,

Michael L.

Intel Customer Support Technician


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Luluyin
Beginner
78 Views

Hello Michael,

Apologies if my previous email was unclear. What I meant to say is that the Dekra contact you provided, as well as distributors in Taiwan, have not responded. Separately, I reached out to another Dekra contact regarding cybersecurity testing, and that contact informed me that they could not provide the DRTU tool.

We need this tool for TX/RX testing as part of the CE & FDA Class II medical device certification process. One of the required certifications is RF testing, which must be conducted by an ISO 17025-accredited laboratory. The lab we have engaged (Intertek) has stated that they require the chipset manufacturer to provide the testing tool in order to proceed with the necessary tests and issue the certification report.

Thank you.

 

Best regards,

Louie

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Mike_Intel
Moderator
23 Views

Hello Luluyin,

 

Thank you for the information provided.  


I will do further research on this matter and post the response on this thread once it is available.

 

If you have questions, please let us know. Thank you.

 

Best regards,

Michael L.

Intel Customer Support Technician


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