DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "ISO 13485: Quality Management System for Medical Devices (London, UK - September 27-28, 2016)" conference to their offering.
This seminar has been designed to provide a comprehensive overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers. The course will review the requirements of ISO 13485 and will compare to ISO 9001 and the FDA's Quality System Regulation. In addition delegates will gain an appreciation of the relationship between ISO 13485 and ISO 14971 Application of Risk Management to Medical Devices'. The benefits of implementing a Quality Management System will be discussed and key advice on handling complaints will be provided.
Programme of Events Includes:
- Introduction to ISO 13485
- Compare the requirements of ISO 13485 and ISO 9001 and update on the ISO 9001:2015 revisions
- Interpretation of ISO 13485 and what it means in practice
- How to achieve ISO 13485 accreditation
- Examples of ISO 13485 non-compliance
- Understanding the roles and responsibilities of quality management in ISO 13485
- The relationship between ISO 13485 and ISO 14971 Application of Risk Management to Medical Devices'
- Compare and contrast the requirements between ISO 13485 and FDA's Quality System Regulation
- Update on the next revision ISO 13485: 2015
- Unannounced Audits - what to expect
- Successful handling of complaints
- Benefits from implementing a QMS
For more information visit http://www.researchandmarkets.com/research/6xz28f/iso_13485