ISO 13485 details the Quality Management System requirements for medical devices from design through end of life - the entire life cycle of a device. The goal is to ensure the device meets customer and all applicable regulatory requirements.
This webinar will give insight to the changes made between ISO 13485:2003 and ISO 13485:2016. Regulators throughout the world have adopted this standard into their systems. This update impacts medical device manufacturers and service providers by placing emphasis in key areas - risk, supply chain, software validation, complaint handling, CAPA, usability and more.
Learning Objectives:
- Overview of 13485 purpose
- Review of changes from the previous version
- Outline the transition to the new standard
- Key benefits from attending this webinar
- Robust understanding of the ISO 13485:2016 changes
- Impact to your organization
- Identify next steps for your transition
