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

Control of Critical Suppliers for Medical Devices:  ISO 13485:2016 perspectives

The ISO 13485 standard represents a Quality Management System base for many regulatory schemes.

With the recent publication of the new Medical Device and In Vitro Diagnostic Regulations, the regulatory framework surrounding Medical Devices evolves and re-enforces the control of external parties (Suppliers, Subcontractors).

The newest revision of the ISO 13485 standard published in March 2016 aims in the very same direction.

 

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 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?

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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.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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