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Process Measurable Objectives

Posted 27th December 2017 at 10:45 AM by sherley13
Updated 27th December 2017 at 10:56 AM by sherley13

Auditor Questions:

Organization specifies its objectives in a rather general manner. It also specifies its processes. It is not clear how the general objectives of the organization are mirrored to the processes and how the measurable...
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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.

Sherley13
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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.

sherley 13
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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

Sherley13
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Laminaria - Biocompatibility Study?

Posted 15th August 2014 at 10:31 AM by sherley13

Laminaria it is Ocean Kelp dried and cut to 60mm size and classified by mm thickness size. It is a natural product of vegetable origin. Being a Class 2 Device by FDA and by Medical Device Directives of the European Union, we are required to study the...
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