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.
Medical Device Studies: Clinical Evidence
9-10 Nov 2020
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
1-2 Dec 2020
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
EC Medical Devices Vigilance System and Post Marketing Surveillance
26-27 Jan 2021
This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.
EC Medical Devices Vigilance System and Post Marketing Surveillance
28-29 Jan 2021
This conference provides a unique opportunity to meet competent authorities, notified bodies, lawyers, consultants and manufacturers to understand and discuss the regulatory and legal requirements with respect to post-marketing surveillance including vigilance.
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
23-24 Feb 2021
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
25-26 Feb 2021
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
1-2 Mar 2021
How to produce quality regulatory documents including the clinical evaluation report (CER)
Medical Writing for Medical Devices
3-4 Mar 2021
How to produce quality regulatory documents including the clinical evaluation report (CER)
New Medical Device Regulation
15-16 Mar 2021
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.
New Medical Device Regulation
17-18 Mar 2021
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.
Advanced Regulatory Affairs for Medical Devices
20-21 Apr 2021
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Advanced Regulatory Affairs for Medical Devices
22-23 Apr 2021
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Medical Device Studies: Clinical Evidence
10-11 May 2021
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
12-14 May 2021
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
17-18 May 2021
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
19-21 May 2021
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
8-9 Jun 2021
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
10-11 Jun 2021
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
The Medical Device Summer School - From Concept to CE Marking
5-9 Jul 2021
*A practical five-day course with interactive workshops - now in its 17th successful year!*
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 Device Studies: Regulatory Requirements and Adverse Event Reporting
20-21 Sep 2021
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
22-23 Sep 2021
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
28-29 Sep 2021
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
Advanced Regulatory Affairs for Medical Devices
30 Sep-1 Oct 2021
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
New Medical Device Regulation
12-13 Oct 2021
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.
New Medical Device Regulation
14-15 Oct 2021
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.
Medical Writing for Medical Devices
19-20 Oct 2021
How to produce quality regulatory documents including the clinical evaluation report (CER)
Medical Writing for Medical Devices
21-22 Oct 2021
How to produce quality regulatory documents including the clinical evaluation report (CER)
Medical Device Studies: Clinical Evidence
8-9 Nov 2021
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
10-12 Nov 2021
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
15-16 Nov 2021
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
17-19 Nov 2021
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
29-30 Nov 2021
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
1-2 Dec 2021
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents