Three Day Introduction to the Medical Devices Directives Seminar - London, United Kingdom - May 8th-10th, 2017 - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "An Introduction to the Medical Devices Directives" conference to their offering.

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.

An Introduction to the Medical Device Directives - this course will help you gain a comprehensive understanding of the regulatory requirements.

Benefits Of Attending

- 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

Agenda

Programme Day One

What is a Medical Device?

- Definition

- Examples

Europe and the Medical Device Directives

- What is a Competent Authority, Notified Body and an Authorised Representative?

- How do they inter-relate?

- Responsibilities of each party

Classification of Devices

- Review of definitions

- The 18 rules

Conformity Assessment Procedures

- Optional routes for each class

- What is required for each class

Workshop 1: Classification

End of Day One

Programme Day Two

Manufacturer’s Responsibilities

- Technical file and design dossier requirements

Quality Systems

- EN ISO 13485

- The requirements for a quality system

Clinical Evaluations

- European Regulatory environment

- When are Clinical Investigations necessary?

- What is required by the Competent Authorities, Ethics Committee and Notified Body?

Workshop 2: Clinical Evaluations

Medical Device Vigilance

- Adverse Event reporting

- Reporting requirements

- Post Market Surveillance (PMS)

Workshop 3: Vigilance

End of Day Two

Programme Day Three

Labelling of Devices

- Use of language and symbols

- Instructions for use

Workshop 4: Labelling

Drug/Device Combinations

- Drug or device?

- Examples of classification

Devices Incorporating Material of Animal Origin

- Animal derived material legislation

- Directive 2003/32/EC

The Draft Proposed Revision to the Regulations for Medical Devices and In-Vitro Diagnostics

End of Conference

For more information about this conference visit http://www.researchandmarkets.com/research/9wc59r/an_introduction

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Medical Devices