Evolution of the internationally recognized quality management systems ISO 13485 standard for the medical device industry:
Embrace the 2016 version!
On March 1st, 2016, the latest revision of ISO 13485, the internationally recognized Quality Management Systems standard for the medical device industry was officially published. ISO 13485:2016 is now here and ready to take over ISO 13485: 2003.
This publication marks the end of years of negotiations and discussions initiated by Experts, Agencies within the ISO working groups for an evolution of the standard. Other international regulatory changes have occurred and are expected to recast the regulatory landscape for medical devices in the years to come. The new version of ISO 13485 however is seen as one of the major evolutions, bringing on a new set of provisions, introducing new challenges but also, a different way for medical device manufactures to approach the implementation of their Quality Management System, putting the emphasis this time on specific key areas.
Medical device and In Vitro Diagnostics device manufacturers are yet taking a step back, evaluating the changes in an attempt to maintain compliance with the new version of the standard while embarking on a smooth transition. To help you comprehend and measure the extent of the new ISO 13485, LNE/G-MED is dedicating this month newsletter’s to the evolutions of the standard to help you embrace the new 2016 version.
The transition period between ISO 13485:2003 and ISO 13485:2016
The evolutions introduced by the 2016 version
ISO 13485:2016 and the emphasis on Risk Management
ISO 13485:2016 and the Medical Device Regulations
ISO 13485:2016: Organization and Documentation
LNE/ G-MED’s transition program to ISO 13485:2016
Transition to ISO 13485:2016 & ISO 9001:2015
We are very excited to announce that LNE/G-MED is holding 2 training sessions on the transition to ISO 13485:2016 and ISO 9001:2015. Both events are planned on the East and West Coast of the United States. Sign up today for our 2 days training course and:
Understand the new concepts and definitions introduced by ISO 9001:2015 and ISO 13485:2016
Identify the new revised High Level Structure (HLS) for ISO 9001:2015
Comprehend the new Regulatory Requirements and purpose for ISO 9001:2015 and ISO 13485:2016
Cross referencing between the old and new versions for a smooth transitions
About the trainer
Florianne Torset-Bonfillou Technical Department Director at LNE/G-MED North America.
Florianne Torset-Bonfillou is a Senior Design Dossier Reviewer and Lead auditor. She is also a qualified trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. Florianne has over 14 years of experience in the Medical Devices Industry from both the Industry and the Notified Body side.
April 28, 29
Soka University of America
1 University Cir,
Aliso Viejo, CA 92656
May 16, 17
The Silver Spring Civic Building
One Veterans Place
Silver Spring, MD 20910
Florianne Torset-Bonfillou, Technical Department Manager at LNE/G-MED North America will help you understand the nature of those changes, what are the main areas of impacts and whether or not a QMS can be compliant for both ISO 9001:2015 and ISO 13485:2016.