Medical Device Regulations (MDR) Training

Oct
9
Date: 9th October 2019 -
10th October 2019
Time: 09:00 - 17:00
Duration: 2 days
Venue: Radisson Blu, Limerick
Address:
Event details

Medical Device Regulations (MDR) Training

Medical Device Regulations (MDR) Training


Introduction:
The legislation outlining the requirements for medical device manufacturers prior to placing them on the market in the European Union is changing.
The old Medical Devices Regulation (EU 2017/745) is to be replaced by the Medical Devices Directive (93/42/EEC). The new regulations place greater emphasis on accountability for all players and with greater scrutiny of both clinical evaluation and post-market clinical evaluations and improved traceability of devices for the full life cycle.


Who should attend:
This training is aimed at those with a working knowledge QMS from all levels within the organisation including (but not limited to):
• Authorised Representatives
• Manufacturing personnel
• Quality
• Regulatory Affairs
• Design and Development
• Economic Operators for example importers and distributors

Course Objectives:
The 2-day course on MDR is highly interactive with many team exercises and discussion. Some of the specific topics covered include the following:
Device and product families MDR implications
Introduction to MDR Manufacturers Article
Classification Documentation Changes
Conforming with MDR UDI
Clinical Investigations Vigilance and PSUR/PMS
Safety Performance Labelling
Authorised Representative MDR Audits and Inspection readiness
Eudamed and MDGC Distribution
MDR and other Certifications / Regulations

Price
Per delegate: €390.00
(plus VAT)
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