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Understanding the European IVD Regulation

Practical tips for early compliance

30 - 31 October 2017

Radisson Blu Edwardian Grafton, London

Aimed at professionals new to IVD regulations or needing an update on recent regulatory changes, this course will provide a thorough understanding of the regulatory requirements for in vitro diagnostics (IVDs) in the European Union.

Expected to be published later this year, the EU IVD Regulation brings radical changes which must be known and understood by the IVD industry in order to ensure the business continuity of each IVD manufacturer. This 2-day course will focus on the new EU IVD-Regulation and will provide the attendees with a detailed comprehension of its most challenging aspects together with practical suggestions on how to start preparing for it.

  • Gain a thorough understanding of how the NEW regulation will impact you as a manufacturer 
  • Learn how to classify IVDs
  • Examine the various conformity assessment routes to ensure successful approvals
  • Understand the role of the Notified Body and Competent Authority
  • Examine the risk management process for IVDs
  • Discuss labelling requirements and strategies

This training will be delivered by one of our two expert trainers below:

Dr Maurizio Suppo has been a Principal Consultant at Qarad since 2012. He was previously the Director of the EDMA. His main responsibilities lay in the regulatory and standardization fields, with primary involvement in the drafting and approval process of the European IVD Directive 98/79/EC.

Dr Dirk Stynen has many years of industry experience, including 7 years spent as a Department Head at Innogenetics, covering Quality Assurance, Quality Control, Regulatory Affairs and Labelling. He has since set up Qarad, assisting IVD and MD companies worldwide in achieving compliance with European Regulations and Quality System requirements.

 

This two-day course is aimed at the following professionals:

  • Those moving into Regulatory Affairs from other areas within a IVD company (R&D, Marketing and others)
  • Those new to the IVD Regulations with a background in medical devices, pharmaceuticals or biotech
  • Professionals working in areas such as marketing or manufacturing wanting a complete update on the IVD requirements

ISO 13485:2016 – An Overview of General and Product Realisation Requirements

Led by Richard Young, trainer for MDTI's 'Managing the Transition to the new IVD Regulation' and 'Practical Guidance for Medical Device Audits and Inspections' courses, this c. 20 minute webinar covers:

- Impacts of the new revision
- New terminology
- General requirements
- Resource management
- Product realisation and design controls
- Q&A session

Medical devices software development and applications

Over c.30 minutes, this webinar explores a major area of development from the last decade. Presented by Richard Young, it covers:

- The changing regulatory environment for medical devices in Europe 
- FDA regulation 
- Key considerations in development environments 
- Key standards 

 

You may also be interested in...

Led by Richard Young this high level 30 minute webinar will be provide you with valuable updates and insights into the new classification system proposed in the new IVD Regulation. You will gain solid grounding in the new risk based approach to classification so you can begin to evaluate your diagnostic products and prepare for the future changes.

  • Regulatory update and impact on the IVD industry
  • Outline of changes to classification: A risk based approach
  • Reviewing Annex VII: Rule 1- 8