Introduction to: ISO 13485 Medical Devices Training Course

Course Description

BSI’s “Introduction to: ISO 13485” one day course has been designed to provide an insight in to the use of ISO 13485:2003 as the basis for a quality management system implemented by medical device manufacturers.  Time will be spent during the course reviewing requirements of ISO 13485 and making comparisons to ISO 9001:2008 and the FDA’s Quality System Regulation.  In addition to this, participants will also gain an awareness of the relationship between ISO 13485 and ISO 14971:2007, “Application of Risk Management to Medical Devices”.

Learning Objectives

On completion of the training, participants will be able to: 

• 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
  

Who Should Attend

• Senior Management
• Quality Managers
• Regulatory Affairs Managers
• Internal and external Auditors
• Anyone involved with the implementation of the standard

Prerequisites

There is no prerequisite from this course but participants will benefit from a basic knowledge of the quality management systems, ISO 9001:2008 or ISO 13485:2003.

Further Information

Fee: One-day course including refreshments, lunch and course notes £535 + VAT.
Attendance on this course will provide delegates with 8 CPD points.