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Janette Benaddi

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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.

New Regulations for Medical Devices and IVDs in Europe Training Course

New Regulations for Medical Devices and IVDs in Europe

24-25 Feb 2022

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

1-2 Mar 2022

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

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

9-10 Mar 2022

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

Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

6-7 Apr 2022

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

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

4-5 May 2022

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

Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

9-10 May 2022

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

An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

18-20 May 2022

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.

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

7-8 Jun 2022

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

The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

13-17 Jun 2022

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.

Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

5-6 Jul 2022

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

An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

1-3 Aug 2022

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.

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

8-9 Aug 2022

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

Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

15-16 Aug 2022

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

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

19-20 Sep 2022

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

Advanced Regulatory Affairs for Medical Devices Training Course

Advanced Regulatory Affairs for Medical Devices

27-28 Sep 2022

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

New Regulations for Medical Devices and IVDs in Europe Training Course

New Regulations for Medical Devices and IVDs in Europe

13-14 Oct 2022

During a period of change and opportunity within the medical technology and diagnostics sectors, this seminar will help you prepare and operate successfully in Europe and the UK post Brexit.

Medical Writing for Medical Devices Training Course

Medical Writing for Medical Devices

19-20 Oct 2022

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

An Introduction to the Medical Device Regulation Training Course

An Introduction to the Medical Device Regulation

8-10 Nov 2022

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.

Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

14-15 Nov 2022

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

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

28-29 Nov 2022

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

The Medical Device School - From Concept to CE Marking Training Course

The Medical Device School - From Concept to CE Marking

5-9 Dec 2022

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.