Introduction to the Medical Devices Directive 93/42/EEC (as amended by Council Directive 2007/47/EC) and ISO 13485: 2003 for global market access.

Introduction

This course is intended to cover the fundamentals of the Medical Devices Directive (93/42/EEC as amended by council directive 2007/47/EC) and ISO 13485:2003 in a real world context to ensure that your product meets the requirements of the patient, you, the manufacturer and the regulatory authorities.

Benefits of attending

• Provide you with the knowledge and tools to:-
• Solve those real life problems
• Be armed with the knowledge for those real life problems yet to happen
• Share experiences with fellow colleagues
• Manage risks through Increased knowledge

Delegates

• Anyone with an interest in regulatory affairs.
• Seasoned professionals for those looking for a Refresher course
• Anyone involved in the production of medical devices
• Regulatory Affairs Professionals
• Quality Assurance, Quality Control Professionals
• Technicians
• Supervisors
• Students

Course Content

• Introduction to the Directive
• Conformity assessment routes
• Technical documentation
• Clinical data
• Non active devices
• Active devices
• Special devices
• ISO 13485:2003
• Using the MDD for access to other world markets
• Workshop
• Examination (optional)

Methodology

One day training course, presented by Jeff Vest.

There will be a mixture of presentations, discussions, workshop and an optional examination.

Presenter

Jeff Vest

With over 12 years of experience of auditing to the regulatory requirements spanning three Notified Bodies, Jeff is currently Manager of the Medical Health Services of the UK office of TÜV SÜD Product Service.  Prior to this appointment, Jeff worked for TÜV SÜD Product Service as a lead auditor for medical devices, joining the company in 2004.

Since 1999 Jeff has been a Lead auditor for medical devices auditing medical device companies in Europe, Americas, Asia and Africa.

Why choose TÜV SÜD Product Service

TÜV SÜD Product Service is the largest EU Notified Body for the Medical Devices Directive, with extensive experience in regulatory approvals. We provide a wide range of training services, sharing our expertise in product and quality system conformance.

Based on real life experiences, we provide you with valuable information in getting your products and services to market on a global basis.

Our expertise is supported by over 50 years’ experience in testing, certification and training, and by over 100 accreditations and approvals and have thousands of clients worldwide. 

For further information please contact Sandie Houghton, SHoughton@tuvps.co.uk.