Since its publication, many articles have been published regarding the potential implications of the new European Medical Device Regulation (MDR) on the CE-marked medical devices within the European Union. However this change of regulation goes further than only the European Union (EU) and affects also other European countries (Not European Union Member-State).
A survey was recently administered by ISO TC210 WG1 to obtain critical information to evaluate the experiences of key stakeholders such as, medical device manufacturers, subcontractors, suppliers, European Authorized Representatives, specialized consulting firms etc., during the ISO 13485:2016 transition. ISO TC210 is a taskforce focused on the quality and performance of medical devices. They have numerous deliverables that consist of, standards, risk management, guidance documents, usability, and quality management, to name a few.
Health Canada published on August 21st, 2018 a notice confirming its “intention to Adopt the Use of the Table of Contents Format for Class III and IV Premarket Medical Device Licence Applications”, a gesture towards the efforts sustained by the IMDRF group to support medical device market authorization requests and encourage the global convergence of documentation requirements for medical devices and in vitro diagnostics.
From one Medical Device Manufacturer to another, from one Notified Body to a Medical Device Manufacturer or from one Competent Authority to a Medical Device manufacturer, from Standards to Standards or Regulations, the word “Performance” can be used in a wide different way.
In the context of EC type and EC Design examinations, LNE / G-MED provides Medical Device Manufacturers with a list of the elements to be supplied for the CE marking of their medical devices. The list shall specify the content of the Dossiers to be submitted to the Notified Body as part of their conformity assessment. LNE / G-MED update this list and through this webinar, inform Medical Device Manufacturers, of the changes to be taken into account for future dossiers submissions.
Update /creation of the list of elements to be provided for the CE marking of a Medical Device in the context of:
• An Initial evaluation • Evaluation of a change • Evaluation of a renewal
The presentation will be followed by a session of questions / answers with our expert.
Topic: CE Marking of Medical Devices: Elements to be provided during the Evaluation of the Technical DocumentationAbout the presenter: Christine QUINTON, Technical File Evaluation Manager - LNE/G-MED
Christine QUINTON is a materials engineer. She consolidated her knowledge in Berlin, where she worked for a medical device manufacturer during four years. After that, she worked as an auditor for a German notified body. In 2004, she joined LNE/G-MED and broadened her areas of expertise. She worked as a Certification Project Manager, an Assessor, an Auditor and a Trainer. Since April 2012, she manages the technical file evaluation activities for class III MDs: harmonization of evaluation practices, qualification of the assessors, and evaluation of the technical files in the Comité de lecture.
Join us on Wednesday, September 27th, 2017, 2:00 pm Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on IVD European Regulation: how QMS requirements interacts with ISO 13485:2016.
On November 1999, the Institute Of Medicine published “To Err Is Human”, a report analyzing the mortality of people in hospitals in the United State (up to 98000 deaths) as a result of medical errors, laying out strategies to “reduce preventable medical errors”. As per this report, medical errors, more commonly “are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them.”
Join us on Wednesday, August 30th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on Usability for Medical Devices: Highlights of the European Regulations and Standards