Compare the requirements of ISO 13485 and ISO 9001, understand the role and responsibilities of quality management. Consider the relationship between ISO 13485 and ISO 14971, Application to Risk Management to Medical Devices
This seminar will provide a comprehensive overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers. It will review the requirements of ISO 13485 and will compare it 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.
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
Successful handling of Post Market issues
Benefits from implementing a QMS
Discussion and workshops will take place throughout the two days
We do not currently have dates confirmed for this course; please contact us to be informed when it is scheduled; or to discuss running this course on an in-house basis for your staff.