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Latest release: March 2018New regulation update on audit and certification

What does Medical Device Clinical Performance stands for?

From one Medical Device Manufacturer to another, from one Notified Body to a Medical Device Manufacturer or from one Competent Authority to a Medical Device manufacturer, from Standards to Standards or Regulations, the word “Performance” can be used in a wide different way.

Depending on one’s background, the answer is always different. Some will say it refers back to the Clinical Performance of a Medical Device while for others, it means both Clinical and Technical performances.

In this newsletter, we want to discuss the different usage of the word “Performance’; the possible confusions between Performances and Characteristics and highlight the common pitfalls when using the word Performance within the European regulatory framework.

 

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 Miscellaneous

 

MDSAP Medical Device Single Audit Program

 

CE

 CE marking / European Medical Device Regulations

 

> CE marking for IVD Devices

 

ISO Quality Management System (QMS)

 

Worldwide regulation

 Worldwide Regulations

Brazil 

Russia 

Mexico 

USA 

 

 

 

Questions?

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Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.