The Council of the European Union announced the publication on Wednesday February 22nd, 2017 of the final draft version for the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
Both texts, respectively 566 pages and 477 pages, have been long-awaited and are now available for consultation.
With over one million certified companies over the world, the international Quality Management System standard ISO 13485 is among the most commonly used.
Since its first publication in 1993, several revisions have taken place aligning the standard with the evolution of the industry and the market needs. 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.
Join us on Wednesday, March 29th at 2:00 pm EDT as LNE/G-MED North America Inc. will be hosting a free informative session on Notification of changes: How, what and when to communicate with your Notified Body?
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.
Based on our experience with ISO 13485 and CE marking audits, most of these topics lead to major non-conformities ( NCs ) which need to be fixed prior to obtaining Certificates and that could therefore impact the certification timeframe.
Welcome to 2017. With the new year rolling in, here come new resolutions … or should we say new Regulations.
In June 2016, political agreements on the medical device and in vitro diagnostics medical device regulations were released and we are expecting these two new European regulations to be voted and published during the year 2017.
These two regulations are bringing numerous changes, so it is crucial for manufacturers, who will be impacted by these changes, to be ready.
For this first newsletter of the year, we will present 5 major changes for each regulation, based on the published political agreements.
Join us on Wednesday, January 25th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
2016 has brought its share of changes and announcements in the applicable regulations and standards. Many actors have already started to perform Gap analysis, build plan, and update their Quality Management System to implement or anticipate these changes.
For our last newsletter of the year, we compiled a summary of those changes, recent and upcoming.