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Latest release: July 2017New regulation update on audit and certification

Cyber security for medical devices: An overview of applicable regulations

An ever increasing number of medical devices are being connected to hospital information networks via various types of connection (4G, Wi-Fi, Bluetooth and Ethernet). At the same time, more and more cases of issues associated with hacking, piracy and even theft of personal medical data are being reported in the media.

It is therefore appropriate to examine the current regulatory position vis-à-vis connected medical devices.

 

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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 

 

 

 

Combo Training ISO13485 MDSAP

Questions?

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clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

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

2 days course 

Click here to Register