Medical Device Regulations (MDR) Two Day Training Program - LIMERICK
January 22 and 23rd 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 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.
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.
Course is held at the Radisson Blu Hotel, Ennis Road, Limerick
Please check here for other locations and dates.
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.
Payment Options
Purchase By Bank Transfer
Please select 'Add to Basket' and proceed to Check Out. At the Checkout select Bank Transfer.
Your order confirmation email will contain an order number please reference this order number when submitting your BAC's payment. The Order is on-hold until we confirm that payment has been received.
Our bank details
Irish Quality Centre:
Bank: Ulster Bank
Account number: 12670866
Sort code: 986280
IBAN: IE24 ULSB 9862 8012 670866
BIC: ULSBIE2D
Purchase by PO
If you wish to pay using a Purchase Order please select Buy Now and proceed to Check Out. At the Checkout select Bank Transfer. You will recieve and email confirmation requesting your PO number be forwarded to info@iqc.ie along with the Order Number referenced in the email.
An invoice will be sent to the billing address you submitted referencing the PO number you have submitted. The Order is on-hold until we confirm that the official PO Number has been received.
Pay by Credit Card
Please select ADD TO BASKET and proceed to Check Out.