ANSI has released a new edition of ISO 13485:2016, the standard for “Medical devices – Quality management systems – Requirements for regulatory purposes.” The revised standard can now be purchased from ANSI’s standards store. According to ANSI, the most significant changes pertain to added requirements:
- document management
- management review
- human resources
- infrastructure
- work environment and contamination control
- planning
- record keeping
- communication with regulatory authorities
- consideration of many aspects of design and development
