Quality Management |
 |
 |
 |
| Written by Graham Stoney | |
|
Biomedical engineering, and much of the regulatory regime that it must comply with, is all about reaching acceptable levels of quality to ensure that your product is safe and effective. Regulations worldwide require you to have a quality system in place in order to market a medical device. ISO 13485: "Medical devices -- Quality management systems -- Requirements for regulatory purposes" dictates what you must do to apply the quality systems framework of ISO 9001 to medical devices, and is a mandatory standard if you're building a medical device. Read the associated technical report ISO/TR 14969: “Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003”. Social Bookmark this page:         
|