ISO/FDIS 13485 Medical devices — Quality management systems — Requirements for regulatory purposes Final draft of ISO 13485:2015 has been circulated and is available from BSI:
ISO 13485:2015 is due to be published early 2016.
The new ISO 13485 is applicable across the whole supply chain and seeks to address the entire life cycle of a medical device.
Some of the key changes include:
* Harmonization of regulatory requirements
* Inclusion of risk management throughout the QMS
* Additional clarity with regard to validation, verification, and design activities
* Strengthening of supplier control processes
* Increased focus regarding feedback mechanisms
* Software for QMS, manufacturing and the medical device
Additional information available from BSI:
* Download the BSI white paper on ISO 13485 – The proposed changes and what they mean for you
* Learn more about the ISO 13485 revision