Medical Device Studies: Regulatory Requirements and Adverse Event Reporting In-house Training

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

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Format: Live online
CPD: 12 hours for your records
Certificate of completion

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Course overview

This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance.

This course is of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Who should attend?

Regulatory affairs specialists
Quality assurance specialists
Clinical research associates
Junior clinical research associates
Professionals involved in reporting adverse events during pre- and post-market clinical studies

The Medical Device Studies: Regulatory Requirements and Adverse Event Reporting course will cover:

Clinical evaluation – an overview

What is a clinical evaluation?
How do you conduct a clinical evaluation?
The regulatory requirements pertaining to clinical evaluation

Clinical investigations – an overview

What is a clinical investigation?
When are clinical investigations needed?
The regulatory requirements

PMS and PMCF

What is PMS?
What is PMCF?
When are PMCF studies necessary?

Quiz on clinical evaluation, clinical investigation and PMCF

New requirements of the MDR

Summary of safety and clinical performance
Periodic safety update report (PSUR)

The competent authority and the Notified Body

What is their role in the above processes?
What are the responsibilities of the manufacturer?
What to communicate and when

Workshop on the new requirements of the MDR

Vigilance reporting

What is vigilance?
The requirements for vigilance reporting during medical device studies

How to define and classify adverse events

Definitions
Types of events
Determining categories

Vigilance workshop

The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies

MEDDEV guidance document
ISO 14155 harmonised standard
Responsibilities
Templates

The MDR – clinical elements

Focus on changes in the clinical arena
Chapter 6: clinical evaluation and investigation
Annex 14: clinical evaluation and post-market clinical follow-up

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.

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