envelope  Contact us

phone1-301-495-0477

Join us on Wednesday, May 24th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives.

Register Now!

 

ISO 13485 2016The publication of ISO 13485:2016 in March last year reinforced the notion of control of supply chain for Medical Device manufacturers. With a clear reinforcement of the risk-based approach in the entire ISO 13485:2016, it is no exception that the Purchasing section (7.4) includes new provisions to strengthen Supplier control.  Requirements are mostly written towards the medical devices legal manufacturer to control its suppliers, however it is critical that suppliers are also aware about them as they could also be ISO 13485 certified. The updated standard gives more details about what companies shall consider in the process of evaluation, selection and monitoring of their suppliers. It not only amends the management of Supplier relationships, but also puts in perspective the whole process of supplier selection.

Join LNE/G-MED and Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality at LNE/G-MED North America, Inc., to understand why Notified Bodies need to ensure control of Critical suppliers by Medical Device manufacturers, how ISO 13485:2016 impacts Critical Suppliers’ processes. You can tune to LNE/G-MED North America’s upcoming free webinar on Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives.

 

REGISTRATION DETAILS
Florianne Torset Bonfillou LNE Gmed

Topic: Control of Critical Suppliers for Medical Devices: ISO 13485:2016 perspectives
Date: Wednesday, May 24th, 2017
Time: 2:00 - 2:30 PM EDT

Presenter: Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc. 
Click here to Register!

MDSAP Prepare the transition, worldwide market access

Combo Training ISO13485 MDSAP

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.

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