Translate MedTech - Regulatory Affairs for Medical Devices

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If for any reason you find that you are unable to attend, please let us know [(0113) 34 37244; email hello@translate-medtech.ac.uk]. Failure to take up a pre-booked place without letting us know with at least 48hours notice will be charged £95 to cover course costs.

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Sales Have Ended

Registrations are closed
If for any reason you find that you are unable to attend, please let us know [(0113) 34 37244; email hello@translate-medtech.ac.uk]. Failure to take up a pre-booked place without letting us know with at least 48hours notice will be charged £95 to cover course costs.
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Translate MedTech - Regulatory Affairs for Medical Devices

This course, delivered as two 3-hour sessions across two separate days, is an introduction to medical devices and the regulatory requirements for placing medical devices on the market and CE marking of devices. It will help you to understand the regulatory path to CE marking a device, deciphering all the regulatory jargon and understanding the new Medical Device Regulations.

By the end of the course, you should be well set up to understand the requirements and responsibilities and plan your organisation’s regulatory and clinical strategy. As well as guiding you through the regulations, it brings you up to scratch with all the other relevant guidance, standards and the new Medical Device Regulations.

*Note - this course will be delivered by the trainer remotely via video conferencing software. Information about how to join the conferencing call will be emailed to everyone that has registered.


Open to academics, researchers, clinicians and industry representatives, by attending the course you will:

  • Learn about the NEW Medical Devices Regulation to be implemented May 2021
  • Learn how to CE mark a device
  • Learn how to classify medical devices
  • Determine the information required for CE marking
  • Understand the role of the Notified Body and the National Competent Authority
  • Learn about the clinical evidence that is required to CE mark a product and the processes involved


Agenda

Day 1: 18 May 2020, 9:30am - 12:30pm

What is a Medical Device?
How you determine if your product is a medical device; what regulations govern the marketing of medical devices; and how devices are classified

The CE Marking process
How to get a CE mark for your device; what the process is; what regulations, guidance and standards you need to follow; and what documentation you need.
Notified Bodies, National Competent Authorities and Authorized representatives - who they are and what do they do.

Workshop on Classification


Day 2: 20 May 2020, 9:30am - 12:30pm

Clinical evidence for medical devices
What evidence you need; when and how you collect it; and what the regulations and guidance applicable to medical device clinical studies are (including clinical evaluation and clinical investigation).

Course Quiz – covering Day 1 and Day 2


The training course will be run by Janette Benaddi, Medipex Associate.

Spaces are limited and registration is essential.

Free to staff and postgraduate research students at Translate partner universities (Bradford, Huddersfield, Leeds, Leeds Beckett, Sheffield Hallam and York).

Places for industry and clinical representatives are available at a cost of £95, please email Mohua Siddique (M.Siddique@leeds.ac.uk) to secure your ticket.

Book now to avoid disappointment.



About the trainer

Medipex is the regional NHS Innovation Hub for the Yorkshire & Humber region helping NHS staff commercialise their ideas and innovations.

Janette Benaddi has over 20 years’ experience of managing pre and post-market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles.

She is the former owner of Medvance Clinical Research Ltd. and former Director of Clinical & Consulting Europe for NAMSA- a company which provides clinical research and regulatory consulting services to the medical device and healthcare industries worldwide.


The registration process is being managed through Eventbrite, a third-party platform that provides a comprehensive event experience for you and us. This means you are providing data to Eventbrite and must agree to their privacy policy terms, and we will also use your data as per our own privacy policy. If you have any questions get in touch via hello@translate-medtech.ac.uk

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