Risk management for global market access - The ISO 14971 / Medical Device Directives / ISO 13485:2003 / IEC 60601-1 world
Risk management for global market access - The ISO 14971 / Medical Device Directives / ISO 13485:2003 / IEC 60601-1 |
Dates and Locations: 26th June 2012 - Birmingham - BOOK HERE 9th October 2012 - Limerick, Ireland - BOOK HERE
Cost: £350, book 30 days before the date of the course and receive 10% discount! Time: 9am - 5pm |
Introduction
Risk management is fundamental to ensuring a safe medical device, the subject is a complex mix of ever changing requirements, not least as the requirements for risk management is now embedded in the IEC 60601-1 3rd edition standard. This course is intended to cover the fundamentals of risk management as called out for in the relevant medical device regulations and standards.
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 risk management.
- 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 Risk management
- How it applies to ISO 13485:2003
- How it applies to the Medical Device Directives
- How it applies to IEC 60601-1
- 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 as a lead auditor for medical devices at TÜV SÜD Product Service.
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.
