envelopecontact us

phone1-301-495-0477

Newsletter

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


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

Initial Certification Audit:  Common Pitfalls for Medical Device Manufacturers

The certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market. 

If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and prepare your initial certification audit.

LNE/G-MED in this edition of the February newsletter, is discussing the most common pitfalls observed during a company’s first audit, pitfalls which may delay or simply prevent the company’s access to market.

 

>

 Miscellaneous

 

MDSAP Medical Device Single Audit Program

 

CE

 CE marking for Medical Devices

 

> CE marking for IVD Devices

 

ISO Quality Management System (QMS)

 

Worldwide regulation

 Worldwide Regulations

Brazil 

Russia 

Mexico 

USA 

 

 

 

combo ISO 13485 9001

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

Don't have an account yet? Register Now!

Sign in to your account