Designed for business leaders with executive responsibilities, this course quickly identifies the areas of strategic impact, possible costs and the time lines associated with the new EU Medical Device Regulations.
The main impact areas are identified and discussed with possible approaches and budget and timeline considerations helping the attendee to scope the impact of these changes for their organisation and begin the process of ensuring continuity of EU market access
The EU MDR will have the largest impact on the diagnostics market since the original implementation of controls in this sector. This is a paradigm shift in the regulations which will impact all manufacturers and have far reaching consequences
The IVDR 2017/746/EEC, review of major impact areas and strategic implications, detailed review of clinical data requirements, product classification, labelling product performance and economic operators.
Organisations must be realistically prepared not only for the impact of changes outlined in the short term, but for the ongoing burden in terms of resources and time required to maintain existing products and bring new products to the market.
Detail examination of:
Updates on the new IVD Regulation
Preliminary Strategic Analysis of the Regulation
Comparison of the Articles
Classification of MDs
General Safety & Performance Requirements
Preparing the Technical Documentation for Notified Body Review
Clinical Evidence for MDs Clinical Investigation and PMCF (External Speaker)
Get fabulous discounts by participating in groups of two or more.
|1||2 Attendees||10% off|
|2||3 to 6 Attendees||20% off|
|3||7 to 10 Attendees||25% off|
|4||10+ Attendees||30% off|
To avail the above group discounts, all the participants should register by making a single payment
Call our representative TODAY on +41 - 43 434 80 33 to have your seats confirmed!