Janette Benaddi

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.

  • 10-12 Nov
  • +4

An Introduction to the Medical Device Regulation

Live online, Classroom
Focused

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours
  • Presented by Ms Janette Benaddi
  • 1-2 Dec
  • +4

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online, Classroom
Focused

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 1-2 Mar 2022-
  • +1

Advanced Regulatory Affairs for Medical Devices

Live online
Focused

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • and Ms Theresa Jeary
  • 9-10 Mar 2022-
  • +2

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online, Classroom
Focused

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 13-17 Dec
  • +2

The Medical Device School - From Concept to CE Marking

Live online
Intensive

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours
  • Presented by Ms Janette Benaddi
  • 6-7 Apr 2022-
  • +2

Medical Writing for Medical Devices

Live online, Classroom
Focused

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

  • 12 CPD hours
  • Presented by Ms Barbara Grossman
  • and Ms Janette Benaddi
  • 12-13 Apr 2022-
  • +2

New Medical Device Regulation

Live online, Classroom
Focused

Managing the transition to the new regulation: this is a seminar you cannot afford to miss as you put in place your strategies for the new environment.

  • 12 CPD hours
  • Presented by Ms Janette Benaddi
  • 9-10 May 2022-
  • +2

Medical Device Studies: Clinical Evidence

Live online, Classroom
Focused

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

  • 12 CPD hours
  • Presented by Ms Janette Benaddi