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.
Join us Wednesday, April 20th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the Evolutions of ISO 9001:2015 and ISO 13485:2016 standards Register now!
In 2012, The International Medical Device Regulators Forum (IMDRF) recognized the value in developing a global approach to auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. It was at that point that the concept for the Medical Device Single Audit...
2 days training course designed and delivered by our expert dedicated to the Transition to the new ISO 9001:2015 and ISO 13485:2016 standards With over one million certified companies over the world, the international quality management systems standards ISO 9001 and ISO 13485 are among the...
LNE/G-MED is coming out in force for the 2016 RAPS. San Jose, CA from September 17 to 21, 2016. The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community.RAPS is the perfect opportunity for our clients to meet and discuss with some of our experts and...
LNE is France’s leading Notified Body and the only one with a role in developing standards. Companies, governments, and NGOs have trusted LNE and its expertise for over 100 years. As it carries on its original role as the metrology and standardization laboratory for France, LNE shares its expertise in standard development and R&D with standards organizations such as AFNOR, CEN, and NIST.
With wide range of certification services, we are committed to helping you understand the critical steps to consider and ensure your device complies with the regulatory requirements from an early stage:
Give you the tools for maintaining compliance
Test and Inspect at various stages of Production and Manufacture
Provide Regulatory and Technical assistance.
LNE/G-MED is a single-source provider of Voluntary and Regulatory certifications and offer complete certification package to save you the time and cost of multiple audits.
Our full range of technical conformity services allows the convenience and efficiency of a US-based team of technical experts, auditors and program managers and makes us one of the leading European Notified Bodies in North America.
Notified Body Code of Conduct and Regulation 920/2013 place an increased emphasis on Notified Body certification staff and their credentials. LNE/GMED‘s long-standing hiring and training practices are serving you well.
Our first consideration when sending auditors is their qualification and expertise with respect to your device and activities.
Our team of Auditors is qualified both for CE marking and QMS assessment to combine your certification needs and reduce your costs.
A dedicated Certification Project Manager very familiar with and available for your certification process and needs is allocated to you. Most of our CPMs are also qualified Lead Auditors and know the auditing and certification processes inside and out.