Medical Device Regulations (MDR) Two Day Training Program - Virtual
October 5 and 6 2020
€699
Introduction to the MDR Two day training
The legislation outlining the requirements for medical device manufacturers prior to placing them on the market in the European Union is changing. The Medical Devices Regulation (EU 2017/745) is replacing 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.
Course Objectives (Summary)
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
As places are limited, book early to avoid disappointment.
Who should attend
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
Need a quote for in-house training email info@iqc.ie
Need a quote for in-house training email info@iqc.ie or phone +353 (0) 1-204 0646
Cancellations
Places cancelled within 10 working days of commencement must be paid in full. Substitutions may be made at any time at no additional charge.