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Medical Writing for Medical Devices Training Course

How to produce quality regulatory documents including the clinical evaluation report (CER)

1-2 Mar 2021

& 3-4 Mar 2021 , 19-20 Oct 2021 , 21-22 Oct 2021

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Details

Course overview

NEW FOR 2020

Writing for medical devices has its own particular skill set and, with important regulatory changes in the industry, all those involved in medical writing face a challenge to ensure they have the necessary expertise and resources to fulfil the requirements of the new regulation.

This comprehensive new course has been designed to provide you with a thorough understanding of the essential aspects of medical writing, with a particular focus on medical devices.

Under the guidance of our expert trainers, you will learn how to prepare a document that is linguistically and stylistically appropriate and understand the effective use of visual elements such as tables, graphs and flow charts. The programme will examine the content and structure of the CER – an integral part of the submission process, and ensure that you are fully aware of what a Notified Body is looking for in your clinical evaluation.

Practical exercises and discussion will consolidate learning, and helpful tips and techniques from experts in the field of medical writing and medical devices will enhance your knowledge.

Who should attend?

  • Medical device professionals responsible for preparing, writing and completing a CER
  • Medical writers producing reports for medical device manufacturers
  • Regulatory affairs personnel involved in preparing scientific documentation
  • Medical device personnel who require a fundamental understanding of what is required when drafting scientific reports for their products
  • Contract research organisations (CROs)
  • R&D professionals

Presenter

Janette Benaddi (More...)

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 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 has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

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1-2 Mar 2021
Face-to-face, (venue not yet confirmed)
1-2 Mar 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 18 Jan 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
3-4 Mar 2021
Live webinar
3-4 Mar 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 20 Jan 21*
Enrol now
to attend
Live webinar
19-20 Oct 2021
Live webinar
19-20 Oct 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 7 Sep 21*
Enrol now
to attend
Live webinar
21-22 Oct 2021
Face-to-face, (venue not yet confirmed)
21-22 Oct 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 9 Sep 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • Biomedical Solutions Inc.
  • Siemens Healthcare GmbH