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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.





MDSAP Medical Device Single Audit Program



 CE marking for Medical Devices


> CE marking for IVD Devices


ISO Quality Management System (QMS)


Worldwide regulation

 Worldwide Regulations








combo ISO 13485 9001


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


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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.

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