ISO 13485:2016

The ISO 13485 standard “Quality Management Systems. Requirements for regulatory purposes” is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan, Canada, South Korea and Brazil, etc.
This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions

Some of the key changes to ISO 13485:2016 include:

• Inclusion of risk management across all process activities
• Additional requirements for design activities
• Additional requirements for process validation and verification activities
• Improvement in supplier control processes using a risk-based approach
• Increased emphasis on feedback methodologies
• Explicit requirements for quality system software
• For outsourced processes control based on risk and ability to meet specifications and requirements
• Detailed requirements in Technical file
• Management Review frequency determination