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ISO 13485: Quality Management System for Medical Devices


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Who should attend?

Quality Managers Quality Assurance Personnel Regulatory Affairs Managers Internal and External Auditors Medical Device Designers and Developers All those who are involved with the implementation

Details

COURSE OVERVIEW

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.

WHY YOU SHOULD ATTEND

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 ISO13485 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.

Prices

GBP EUR USD Standard 1399 1959 2182 Excluding VAT @ 20.00%

Contact

Leigh White
info@management-forum.co.uk

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