ISO 13485: 2016 Medical Devices

• Regulatory officers
• Quality managers
• Professionals tasked with overseeing a management system meeting ISO 13485 standards
• Medical device companies looking to set up their QMS and get ISO 13485:2016 certified

At the end of this course, you should gain knowledge and skills to:

• Conduct a baseline review of an organisation’s current position with regards to ISO 13485
• Prepare the documents as required by the ISO13485 Standard
• Understand the approaches, methods and techniques used for the implementation and management of a MDQMS
• Apply a process approach and/or systems thinking approach to ISO 13485 implementation
• Apply the plan, do, check & act (PDCA) model to the Implementation of your QMS
• Verify the implementation process

• Gain an understanding of how to document and implement a QMS in a systematic manner in line with the Standard and regulatory requirements
• To gain the confidence to initiate steps towards certification
• Identify current quality systems gaps in your own operations

• Training course materials containing practical examples
• Lunch and Refreshments (for face to face training)
• Certificate