Join us on Wednesday, September 26th, 2018, 2:00 Eastern Time as GMED North America Inc. will be hosting a free informative session on Stepping into an MDSAP audit.
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.
The webinar addresses the following main points:
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.
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.”
An ever increasing number of medical devices are being connected to hospital information networks via various types of connection (4G, Wi-Fi, Bluetooth and Ethernet). At the same time, more and more cases of issues associated with hacking, piracy and even theft of personal medical data are being reported in the media.
It is therefore appropriate to examine the current regulatory position vis-à-vis connected medical devices.