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Janette Benaddi

portrait

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 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)

UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course

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 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

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 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.

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

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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 Training Course

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.