Essentials of European Medical Device Regulatory Affairs

Essentials of European Medical Device Regulatory Affairs
This one-day course will provide a comprehensive overview of regulatory requirements and considerations for medical devices.


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When: 21 June 2018
Where: Treacys Oakwood Hotel Shannon, Airport Road, Shannon, Ireland

Whether you are a new recruit working regulatory affairs for devices, or are an experienced regulatory professional in the world of medicines, this course will give you the overview you need. 


    What is it?
    The aim of the course is to provide an insight into the regulatory requirements for Medical Devices in the EU. Whether you are a new recruit working regulatory affairs for devices, or are an experienced regulatory professional in the world of medicines, this course will give you the overview you need. 


    Who is it for?
    This course is suitable for:
    • Regulatory affairs professional who requires a comprehensive overview of medical devices regulatory affairs.
    • Professionals who work in functions allied to medical device regulatory affairs such as marketing, medical, quality, packaging, legal, etc.
    • Those working in an administrative capacity alongside medical device regulatory affairs requiring an overview of device regulatory affairs and those returning to work after a career break.

     

    What will I learn?
    This course will cover
    • What is and what is not a medical device.
    • The European legislation and guidelines concerning medical devices.
    • The role of the competent authority.
    • The role of the notified body.
    • The classification of medical devices.
    • The “Essential requirements” of a medical device.
    • The documentation that is required to support a medical device.
    • The declaration of conformity and the CE mark Device labelling.
    • Clinical evaluation.
    • Post marketing activities.
    For a more detailed introduction to regulatory affairs for Medical Devices, you may wish to consider our 3-day residential course instead. Please email us for more information. 


    Download the programme


    CPD: 5

     

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        How do I apply? 
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        Prices 

        		  
        Standard £360+23%VAT 
        Discounted places
        A limited number of discounted places are available at the rates below. Please email us for a discount code before making your booking.
        Those working for regulatory agencies, government agencies or academic institutions 
        		  £270+23%VAT
        Those working for charities, patient groups or are in full-time education
        		  £180+23%VAT

         

        Terms and conditions 
        Please read the training terms and conditions before booking this course. By booking a place on this course you are agreeing to the training terms and conditions.

         
      When
      21/06/2018 09:00 - 16:00
      Where
      Treacys Oakwood Hotel Shannon Airport Road SHANNON IRELAND
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