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  • Last Time Logged In: 21st August 2018 10:57 AM
  • Registration Date: 26th March 2013
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Posted 27th December 2017 at 10:45 AM by sherley13 Comments 0
Posted in Uncategorized
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...

Posted 1st June 2016 at 12:29 PM by sherley13 Comments 0
Hi All,

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


Posted 29th May 2016 at 01:53 PM by sherley13 Comments 1
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

Posted 29th May 2016 at 01:49 PM by sherley13 Comments 0
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


Posted 15th August 2014 at 10:31 AM by sherley13 Comments 1
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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You can get the abstract...
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Thank you for answer...
Posted 1st August 2014 at 10:48 AM by sherley13 sherley13 is offline
Here is my opinion based...
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Hello everyone,
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