In this In-house course provides a comprehensive overview of the requirements of ISO 13485
This In-house course 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 In-house 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.
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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 RegulationUnannounced Audits
Successful handling of Post Market issues
Benefits from implementing a QMS
Discussion and workshops will take place throughout the two days
Will Burton, the Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical and biotechnology industry sectors. Prior to founding RSQA in 1995, Will was the Professional Services Manager of the Manufacturer Registration Scheme Business Unit of the UK Medical Devices Agency (now MHRA). He is a Pharmacist, Medicinal Product Qualified Person, Medical Device Expert and registered international lead assessor. Will managed the UK team of medical device expert assessors performing worldwide quality systems audits of medical device manufacturers against the requirements of the Department of Health’s Quality Systems Documents which formed the foundation for ISO 13485. He has very extensive auditing and quality systems experience and was closely involved in the selection, training and monitoring of UK Notified Bodies. Will continues to perform QMS audits to ISO 13485 worldwide and has lectured internationally on related topics.