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.

  • Next: 26-29 Feb 2024 Live online
  • Also: 9-10 May 2024 Live online
  • Also: 5-6 Aug 2024 Classroom
  • Also: 27-28 Nov 2024 Live online

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

Live online, Classroom

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 13-14 Mar 2024 Live online
  • Also: 1-2 Jul 2024 Live online
  • Also: 21-22 Nov 2024 Live online

Medical Writing for Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 18-21 Mar 2024 Live online
  • Also: 10-11 Jul 2024 Live online
  • Also: 11-12 Nov 2024 Live online

Medical Device Studies: Clinical Evidence

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 15-17 May 2024 Live online
  • Also: 31 Jul-2 Aug 2024 Classroom
  • Also: 4-6 Nov 2024 Live online

An Introduction to the Medical Device Regulation

Live online, Classroom

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.

  • 18 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 21-22 May 2024 Live online
  • Also: 16-19 Sep 2024 Live online

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 4-7 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Advanced Regulatory Affairs for Medical Devices

Live online

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

  • 12 CPD hours Focused
  • Presented by Janette Benaddi
  • Next: 10-14 Jun 2024 Classroom
  • Also: 2-6 Dec 2024 Live online

The Medical Device School - From Concept to CE Marking

Summer school

Live online, Classroom

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.

  • 30 CPD hours Intensive
  • Presented by Janette Benaddi
  • Next: 15 Jul 2024 Live online
  • Also: 19 Nov 2024 Live online

UK Conformity Assessed (UKCA) Marking for Medical Devices

Live online

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.

  • 6 CPD hours Focused
  • Presented by Janette Benaddi