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.

Medical Device Regulations | Limerick | 22 & 23 Jan 2020

€699.00

The legislation outlining the requirements for medical device manufacturers prior to placing them on the market in the European Union is changing.

If you are purchasing the course on behalf of a colleague please fill in the details below so we can email important course material. If there are additional attendees please add there details in the Additional Attendee section at checkout.

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