Quality Training

Medical Device Regulations (MDR) Training 1 day programme

Introduction

Irish Medtech Skillnet in association with Irish Quality Centre (IQC) offer a one day Medical Device Regulations (MDR) Training. This one day event focuses on 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 postmarket clinical evaluations and improved traceability of devices for the full life cycle.

Content includes

The 1-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
    • MDR implications
    • Manufacturers Article
    • Documentation Changes
    • UDI
    • Vigilance and PSUR/PMS
    • Labelling
    • MDR Audits and Inspection readiness
    • Distribution

    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

Upcoming dates:

Location
Dates

Castletroy Park Hotel, Castletroy, Limerick
4 July 2019
Book now

Course

Medical Device Regulations (MDR) Training 1 day programme

Training Days

1 Day

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €175
Non-member rate: €235
* Cost quoted per person