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.
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.
The Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) were initially proposed in 2008 when the EU Commission triggered a consultation on the community’s existing requirements covering medical devices. The plan was 1st released by the commission in 2012 to modify the EU’s medical device regulatory framework along with a proposed regulation replacing the EU’s current Medical Device Directive93/42/EEC, the EU’s directive on Active Implantable Medical Device90/385/EEC, and the In Vitro Diagnostic Directive 98/79/EEC.
Within the last few years, the Medical Device industry has witnessed a series of changes. The last one took place on April 5th, when the EU Parliament concluded years of tractions and discussions with the vote of the Medical Device and In Vitro Diagnostic Regulations.
What began in 2012 at the initiative of the European Commission came to an end during the plenary session of April 5th, 2017, with the adoption by the European Parliament of the new regulations on Medical and In Vitro Diagnostic Medical Devices (MDR and IVDR).
Join us on Wednesday, April 26th, 2017, 2 PM EDT as LNE/G-MED North America Inc. will be hosting a free informative session on the Medical Device and In Vitro Diagnostic regulations, the common changes and timelines introduced by the regulations, and what impact can manufacturers expect.
The Medical Device Industry has always been one of the most demanding when it comes to satisfying its stakeholders.
Satisfying and embracing the needs of multiple actors (market evolution, patient safety, investors, regulators and supply chains) has obligated Legal Manufacturers of medical devices to adapt to change in order to remain viable and in demand.
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.
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.