Overview:

The ISO 13485 Introduction course has been designed to provide an insight into the use of ISO 13485:2003 as the basis for a quality management system implemented by medical device manufacturers.

During this ISO 13485 Introduction course, time will be spent reviewing requirements of ISO 13485 and making comparisons to ISO 9001:2008 and the FDA’s Quality System Regulation.

Candidates will also gain an awareness of the relationship between ISO 13485 and ISO 14971:2007 from this Introduction to ISO 13485 course.

Benefits:

Benefits of the ISO 13485 Introduction course:

• Compare the requirements between ISO 13485 and ISO 9001
• Interpret the clauses of ISO 13485 using ISO 14969:2005
• Recognize the role and responsibilities of management in ISO 13485
• Recognize the relationship between ISO 13485 and ISO 14971
• Compare the requirements between ISO 13485 and FDA’s Quality System Regulation
• Appreciate the use of ISO 13485 as the basis of Medical Device Regulations worldwide

Course details:

Course details of the ISO 13485 Introduction course:

Usual duration: One day

Training buyers can use comparecourse.com to compare ISO training courses from across the UK, by finding training companies who deliver in key cities including London, Manchester, Leeds, Sheffield, Birmingham, Bristol, Swindon, Cardiff, Liverpool, Newcastle, Nottingham, Leicester, Coventry, Norwich, Cambridge, Ipswich, Reading, Southampton, Oxford, Glasgow, Edinburgh and Belfast.