Gain a comprehensive understanding of the regulatory requirements
This seminar provides a detailed introduction to the European medical device legislation. It will explain the Directives and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark.
This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.
Why you should attend
An Introduction to the Medical Device Directives ~ this course will help you gain a comprehensive understanding of the regulatory requirements.
BENEFITS OF ATTENDING
This seminar provides a detailed introduction to the European medical device legislation. It will explain the new regulations and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do. It will also cover the documentation necessary to apply for the CE Mark. This is an excellent introduction from leading experts in the field and delegates should expect three comprehensive days of training.
- Learn the role of a Notified Body
- Know what a Competent Authority expects
- Better under Conformity Assessment Procedures, Classification, Medical Device legislation
- Comply with Manufacturing Responsibilities
- Consider the requirements for Quality Systems
- Plan your Clinical Evaluations
* Please note, events may be cancelled due to commercial or organisational reasons. In this case Research and Markets will refund all registration fees which have already been paid. Research and Markets will not refund any charges arising from the participant having to cancel or re-book transportation or accommodation which he or she has arranged.
Day one Tutor: Janette Benaddi
09.30 Welcome and introduction
09.45 What is a medical device?
11.15 Europe and the Medical Device
Regulation - overview of the regulations applicable for bringing a medical device to market
13.30 What is a Competent Authority,
Notified Body and an Authorised Representative?
How do they inter-relate?
Responsibilities of each party
14.30 Classification of devices
What are the classes and how do we classify devices
15.45 Conformity Assessment Procedures
The routes to CE marking
What is required for each class of device
16.30 Workshop 1: Classification
17.15 End of day one
Day two Tutors: Will Burton and Janette Benaddi
09.00 Manufacturer’s responsibilities
Technical file and design dossier requirements
10.00 Quality systems
EN ISO 13485: 2012 and 2016
The requirements for a quality system
11.15 Labelling of devices
Use of language and symbols
Instructions for use
13.30 Workshop 2: Labelling
14.30 Clinical evaluations
European regulatory environment
When are clinical investigations necessary
What is required by the Competent Authority, Ethics Committee and Notified Body
16.00 Workshop 3: Clinical evaluations
17.00 End of day two
Day three Tutors: Janette Benaddi and Theresa Jeary
09.00 Medical device vigilance
Adverse event reporting
Post Market Surveillance (PMS)
10.00 Workshop 4: Vigilance
11.15 Drug/Device combinations
Drug or device?
Examples of classification
13.30 Devices incorporating material of animal origin
Animal derived materials legislation
15.00 The revision to the regulations for medical devices
15.45 Question and answer session
16.00 End of seminar
Ms Janette Benaddi,
Director of Clinical & Consulting Europe ,
Janette Benaddi is 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.
She has over 20 years’ experience of managing pre and post market clinical studies in both devices and pharmaceuticals. She 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.
She is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction and a Diploma in Management studies, she 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. She has published several articles relating to medical device regulation and clinical studies.
Mr Will Burton,
Russell Square Quality Representatives (RSQR) Ltd
Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. He managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. He continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.
Ms Theresa Jeary,
Technical Manager for Medical Devices ,
Lloyds Register Quality Assurance (LRQA)
Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person.
Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.
Her first introduction to the Medical device Industry was as the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products, with the core technology utilizing bovine collagen.
Having been impressed by the innovative nature and speed of development in the Medical Device Industry, Theresa then pursued a move to the other side of the “fence” and into the Notified Body world of Conformity Assessment. First, at BSI as a Certification Manager in the General Device group, and now with Lloyds Register Quality Assurance (LRQA).
Over the years, Theresa has conducted many successful consultations with a large number of the European Competent Authorities as well as the European Medicines Agency (EMA) as well as reviewing the classification of borderline products.
At LRQA, Theresa is the Technical Manager for Medical Devices with responsibility for Devices Drug products and Class III Medical Device Conformity Assessments for a wide range of medical devices including In-Vitro Fertilization Media and Solutions for Organ Preservation.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.