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Preparing an X hi/lo-R Chart in Datalyzer

Posted 3rd June 2016 at 03:17 PM by bobdoering (Bob Doering)

Good news! We have verified that the Datalyzer software is capable of doing X hi/lo-R charts for precision machining!
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File Type: docx X hi lo-R charts in Datalyzer.docx (110.9 KB, 100 views)
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IEC 62366 - Usability Test Protocol format

Posted 1st June 2016 at 12:29 PM by sherley13

Hi All,

IEC 62366 Application of usability engineering to medical devices - Medical Device Usability Testing any PROTOCOL / or Format available please share with me.

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Medical Device Clinical Evaluation Standard Operating Procedure / SOP

Posted 29th May 2016 at 01:53 PM by sherley13

Dear All,

Recent ISO 13485 Auditors has been asking for Post Market Surveillance procedure ( SOP)/for Medical devices if you have anyone please share with us.

Thank you.

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Post Market Surveillance procedure/ SOP Medical devices

Posted 29th May 2016 at 01:49 PM by sherley13

Dear All,

I am looking for an Clinical evaluation standard operating procedure /SOP for medical devices. if you have anyone please share with me.

Thank you

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Unilateral Tolerance Capability Calculation

Posted 17th May 2016 at 09:07 AM by bobdoering (Bob Doering)
Updated 18th May 2016 at 08:06 AM by Marc

Capability indices and calculations are tough enough as it is, but a common approach of using Cpu or Cpl ("half Cpk's") is statistically incorrect. It assumes the data is normal - which is unlikely as you approach the physical limit (0 for...
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File Type: pdf unilateral tolerance capability calculation.pdf (152.7 KB, 360 views)
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