ISO 13485: Quality Management System for Medical Devices

ISO 13485: Quality Management System for Medical Devices is a conference dedicated to an overview into the use of ISO 13485 as the basis for a Quality Management System (QMS) for medical device manufacturers.

Topics

• Compare the requirements of ISO 13485 and ISO 9001 and update on the ISO 9001:2015 revisions
• Introduction to ISO 13485
• How to achieve ISO 13485 accreditation
• Interpretation of ISO 13485 and what it means in practice
• Understanding the roles and responsibilities of quality management in ISO 13485
• Examples of ISO 13485 non-compliance
• Compare and contrast the requirements between ISO 13485 and FDA’s Quality System Regulation
• The relationship between ISO 13485 and ISO 14971 ‘Application of Risk Management to Medical Devices’
• Unannounced Audits – what to expect
• Update on the next revision ISO 13485: 2015
• Benefits from implementing a QMS
• Successful handling of complaints

Who should Attend

• Quality Assurance Personnel
• Quality Managers
• Internal and External Auditors
• Regulatory Affairs Managers
• All those who are involved with the implementation
• Medical Device Designers and Developers