ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...
ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...
For most high tech companies, developing profitable new products is their entire reason for being.
One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...
The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...
Many organisations still operate without a central, shared Document Management System (DMS) that effectively m...
Cognidox’s commitment to improving usability and cross platform accessibility continues with the release of v1...
If you took a snapshot of document management around 20 years ago, the general situation was that in my indust...
Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...
Managing an NPI process can be fraught with difficulty as each new initiative brings with it the potential for...
