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Medical Device Regulations (MDR) Two Day Training Program - LIMERICK 

January 22 and 23rd 2020 


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 
Documentation Changes 
Conforming with MDR 
Clinical Investigations 
Vigilance and PSUR/PMS 
Safety Performance 
Authorised Representative 
MDR Audits and Inspection readiness 
Eudamed and MDGC 
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 
Regulatory Affairs 
Design and Development 
Economic Operators for example importers and distributors 
Need a quote for in-house training email 
Need a quote for in-house training email or phone +353 (0) 1-204 0646 
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 

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 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. 
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