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SOURCE Research and Markets
DUBLIN, March 1, 2018 /PRNewswire/ --
The "ISO 13485: Quality Management Systems for Medical Devices" conference has been added to ResearchAndMarkets.com's 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.
Why you should attend
Who Should Attend:
Introduction to ISO 13485 and Medical Device Regulation Conformity Assessment
Introduction to the EU Medical Devices Regulations
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 for the QMS requirements in the MDR
How to achieve ISO 13485 certification
Examples of ISO 13485 non-compliances
Understanding the roles and responsibilities of top managment 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 Unannounced Audits
Successful handling of Post Market issues
Benefits from implementing a QMS
Discussion and workshops will take place throughout the two days
For more information about this conference visit https://www.researchandmarkets.com/research/4lcm3w/iso_13485?w=5
Laura Wood, Senior Manager
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