envelope  Contact us



If you missed one of our Newsletters, simply login to download it in PDF.

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.





MDSAP Medical Device Single Audit Program



 CE marking / European Medical Device Regulations


> CE marking for IVD Devices


ISO Quality Management System (QMS)


Worldwide regulation

 Worldwide Regulations








We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

Get a quote proposal


clientsWe're Hiring!

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