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Seminar Price Details

Seminar Fee for One Delegate
Price : US$1,199.00

Register for 5 attendees
Price : US$5,995.00

Register for 10 attendees
Price : US$11,990.00



**Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar.
  • Course Description
  • Agenda
  • Price
  • Speaker
  • Venue

Overview

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

Why you should attend

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 

Areas Covered in the Session

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.

Learning Objectives

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.

  • Medical Devices are undergoing a increase in the expected regulatory burden The final form of the regulations is now set. The new regulations need to be considered now as impacting on decisions today. A clear understanding of the areas of change, the impacts and the strategic solutions needs to be developed and modified as the situation develops.
  • This course is aimed to provide attendees with the insight and tools to plan and implement their organisations strategy for continued access to the European market by the deadlines set in the new regulations.
  • The course is designed to review critical elements of the new regulations and will be run as an interactive course designed for business leaders with a good working knowledge of current requirements.
  • This will include
  • Review of structure of the new regulation
  • Overview of impact areas of regulatory change

Detail examination of:

  • Product Classification
  • Transition arrangements
  • Technical documentation requirements
  • Unique device identification
  • Economic operators
  • Technical and clinical data

Who Will Benefit

  • Regulatory Leaders
  • Business Strategy Leaders
  • Legal Representative
  • Risk management Staff

Agenda

Day 1 Schedule

Introductions

  • Course goals
  • Initial questions

Updates on the new IVD Regulation 

  • Gain an overview of regulation 
  • Why was the Regulation created?

Preliminary Strategic Analysis of the Regulation

  • What does the new Regulation mean for manufacturers?
  • Where are we now? 
  • Examining timelines and the IVD Regulation transition period
  • Addressing the implications of having no grandfather clause 

Comparison of the Articles

  • Review Key Articles

Common Specifications

  • History of current CTS documents
  • Comments on MDCG 
  • Reference Laboratories
  • New CS documents

Structure

  • Manufacturers Obligations
  • The Authorised representative

Classification of MDs

  • Assessing the new MDs classification system outlined in the new Regulation
  • Addressing the new risk based approach to classification 
    • Inherent risk to the patient / population 
    • Novelty 
    • Complexity
  • Step by step guide to classification 
  • Evaluating the impact of the new classification system on manufacturers
  • Specific examination of Active devices software and electromedical products

Strategic Discussion

  • What are the options that can be considered for a manufacturer?
  • How do we present these to organisational leaders?

Day 2 Schedule

General Safety & Performance Requirements

  • Review of all clauses

Responsible Persons

  • Assessment and Impact and qualifications 

Preparing the Technical Documentation for Notified Body Review

  • Strategic guidance for preparing technical documentation ready for NB review
  • A step by step guide to constructing compliant technical files 
  • Gain an understanding of the design dossier
  • Essential Requirements

Economic Operators

Structure

  • Manufacturers Obligations
  • The Authorised representative

Clinical Evidence for MDs Clinical Investigation and PMCF (External Speaker) 

  • Overview of clinical data requirements in accordance with the current Directive
  • Reviewing the clinical performance study changes 
  • Evaluating the increase in transparency with safety data published on EUDAMED database
  • Proving scientific validity through clinical data
  • Clinical study planning and provisions
  • Protocols informed, consent, patient brochures
  • Strategic review of approaches

 

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Group participations

Get fabulous discounts by participating in groups of two or more.

No Attendees Discount
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!

Richard Young

Managing Director,
Acclaim Biomedical Consulting Ltd


Richard Young's core skills can be broadly divided into 4 main areas Regulatory Affairs, GMP (Quality Assurance), GLP (Laboratory Testing) and GCP (Clinical). These core skill areas have been developed over 2 decades of experience with products ranging from class 3 devices such as Orthopaedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardio vascular products. Richard brings a blend of pragmatism and experience to these disciplines that facilitates insightful problem solving approaches as well as solid solutions.

Richard has also had broad experience in a wide range of materials and manufacturing technologies including sterilisation, plastic moulding, software development, electronic medical devices, ceramics, CNC machining, plasma coatings, packaging, extrusion and automated assembly. QUALIFICATIONS & CORE TRAINING IEC 60601 Electrical Safety, University of Liverpool Software Validation Project Management B600 Foundations for Senior Managers Stage 1 MBA (Open University) Lead Assessor ISO13485/ISO9001 for Medical Devices, GMP, GLP

Venue

Location: Coming Soon
Hotel: Coming Soon