DUBLIN–(BUSINESS WIRE)–The “An Essential Overview of the Medical Device Industry Training Course” conference has been added to ResearchAndMarkets.com’s offering.
The course has been specifically designed to meet the needs of those working in pharmaceuticals and in allied business functions who need to understand the medical device sector. It will be particularly relevant for regulatory staff and those in clinical research, medical affairs and business development.
The medical device and diagnostics sectors are entering a period of regulatory change with the implementation of the new Medical Device Regulation (MDR) in 2020.
This interactive one-day course will provide you with the key information necessary to understand the regulation of medical devices and diagnostics, and to appreciate the key differences from pharmaceutical regulation.
Our expert trainers will discuss the transition and implementation of the MDR and will cover the new rules and approaches to developing combination products.
The important interface with digital technology will also be explored, alongside the impact of Brexit. There will be ample opportunity for discussion throughout the day to ensure you come away with a good understanding of the medical device industry.
Key Topics Covered:
What is a medical device and an IVD?
How is the device market developing?
An overview of the MDR and IVD Directives and the Regulations
Challenges of MDR implementation – May 2020
Preparation for IVDR implementation
What are the key differences in approach from pharmaceuticals?
Who are the key actors?
The role of the competent authority and authorised representative
Brexit update – impact on the medical device industry
What is a Notified Body?
How to work with a Notified Body
How are medical devices and IVDs evaluated?
What are the data requirements?
Clinical trial controls for devices
Device vigilance versus pharmacovigilance
Device/drug combination products and companion diagnostics
The operation of Article 117 and the latest guidance
Building a global approval strategy on an EU CE mark approval
The key interface with digital technology
For more information about this conference visit https://www.researchandmarkets.com/r/ngmog1
Contacts
ResearchAndMarkets.com
Laura Wood, Senior Press Manager
[email protected]
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