envelope  Contact us

phone1-301-495-0477

Newsletter

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.

 

>

 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?

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

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

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.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

Click here to Register


 

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

Click here to Register

Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager