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.
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.
27-28 Sep 2022
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
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.
19-20 Oct 2022
How to produce quality regulatory documents including the clinical evaluation report (CER)
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.
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.
24-25 Nov 2022
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
28-29 Nov 2022
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
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.
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.
2-3 Feb 2023
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
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.
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.
27 Feb-2 Mar 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
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.
15-16 Mar 2023
How to produce quality regulatory documents including the clinical evaluation report (CER)
20-23 Mar 2023
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
4-5 May 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
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.
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.
6-9 Jun 2023
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
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.
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.
4-5 Jul 2023
How to produce quality regulatory documents including the clinical evaluation report (CER)
12-13 Jul 2023
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
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.
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.
7-8 Aug 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
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.
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.
9-10 Oct 2023
Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)
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.
13-14 Nov 2023
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
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.
23-24 Nov 2023
How to produce quality regulatory documents including the clinical evaluation report (CER)
29-30 Nov 2023
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
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.