Janette Benaddi
Janette Benaddi is an Independent Consultant and previously the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services form preclinical to post market activities throughout the medical device product development cycle.
Janette 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 has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
Janette is a registered nurse, 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: 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
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
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
19-20 Oct 2022
How to produce quality regulatory documents including the clinical evaluation report (CER)
UK Conformity Assessed (UKCA) Marking for Medical Devices
3 Nov 2022
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
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
24-25 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
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
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.
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
18-19 Jan 2023
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
2-3 Feb 2023
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Introduction to the Medical Device Regulation
7-9 Feb 2023
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.
New Regulations for Medical Devices and IVDs in Europe
21-24 Feb 2023
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.
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
27 Feb-2 Mar 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
UK Conformity Assessed (UKCA) Marking for Medical Devices
3 Mar 2023
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
Medical Writing for Medical Devices
15-16 Mar 2023
How to produce quality regulatory documents including the clinical evaluation report (CER)
Medical Device Studies: Clinical Evidence
20-23 Mar 2023
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
4-5 May 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
9-10 May 2023
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
An Introduction to the Medical Device Regulation
17-19 May 2023
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.
Advanced Regulatory Affairs for Medical Devices
6-9 Jun 2023
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
The Medical Device School - From Concept to CE Marking
12-16 Jun 2023
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.
New Regulations for Medical Devices and IVDs in Europe
29-30 Jun 2023
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
4-5 Jul 2023
How to produce quality regulatory documents including the clinical evaluation report (CER)
Medical Device Studies: Clinical Evidence
12-13 Jul 2023
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
UK Conformity Assessed (UKCA) Marking for Medical Devices
17 Jul 2023
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
An Introduction to the Medical Device Regulation
2-4 Aug 2023
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
7-8 Aug 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
18-21 Sep 2023
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
New Regulations for Medical Devices and IVDs in Europe
2-3 Oct 2023
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
9-10 Oct 2023
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
An Introduction to the Medical Device Regulation
6-8 Nov 2023
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
13-14 Nov 2023
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
UK Conformity Assessed (UKCA) Marking for Medical Devices
21 Nov 2023
With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.
The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.
This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.
Medical Writing for Medical Devices
23-24 Nov 2023
How to produce quality regulatory documents including the clinical evaluation report (CER)
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
29-30 Nov 2023
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
4-8 Dec 2023
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.