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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 2nd December 2017 at 08:59 PM by bobdoering

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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The ink is dry(ing) on the revision of ISO 14001:2015. Is the payoff worth the price

Posted 14th June 2015 at 02:42 PM by LEJoh

The work of writing the new standard is done. Over the summer countries involved in helping to develop the international standard to promote robust, credible and reliable environmental management systems will be reviewing the Final Draft International...
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ISO 13485. Is it worth to the Medical Device Industry.

Posted 29th May 2015 at 09:33 AM by somashekar

While the ISO 13485 is the medical devices QMS - requirements for regulatory purposes., where are the CBs about regulatory purposes. Is it not the domain of the CB with competency built in its auditors to audit and report the applicable regulatory compliance...
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GHG Emissions - Can a Prevention is better than Cure strategy help

Posted 20th October 2014 at 08:46 AM by Dr. L. Ramakrishnan

This subject has been bothering me for quite sometime. I can not understand the procrastination of nations to address the use of fossil fuels.

We all know that with the use of more and more fossil fuels like coal and petroleum products,...
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