When: 27 February 2018
Where: TOPRA, 6th Floor, 3 Harbour Exchange, South Quay, London, E14 9GE, United Kingdom
What is it?
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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 an experienced regulatory professional in the world of medicines, this course will give you the overview you need.
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Who is it for?
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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.
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What will I learn?
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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.
CPD: 5
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How do I register?
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Simply login or create an account and register below.
Prices
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Standard |
£360+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.
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Those working for regulatory agencies, government agencies or academic institutions
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£270+VAT
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Those working for charities, patient groups or are in full-time education
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£180+VAT
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