By Nikhil Chauhan
There's no doubt, medical devices are saving the most precious elements of nature – people's lives. The World Health Organization's video below highlights the importance of medical devices to health care. Medical devices need to be secure and safe. My colleague Santhosh elaborated in a recent blog post on how FDA's 510(k) process is under scrutiny amidst the growing medical device recalls.
FDA recognizes IEC 62304 that acts as a fantastic framework for the device vendors to develop, maintain and validate the medical device software. In order to focus on their differentiators, the device vendors rely on commercial off the shelf software. This third party software is categorized under SOUP (Software Of Unknown Provenance) of IEC 62304. So, device vendors include SOUP compliance requirements while dealing with software vendors such as Wind River Systems. Ken Herold elaborated on this in a recent blog post.
- Quality and Cost – device is robust, installs easily, and is cost competitive.
- Compliance and Safety – built on platform that enables safety and provides risk mitigation, is ready for the approval process and complies with local regulations.
- Reliability - ensure that device does not become unavailable because of vulnerabilities.
- Security - malicious attacks must not extract unauthorized device data. Not even the human body is immune from hackers.
As Bill Graham pointed out in his recent blog post, the release of Wind River Platform for Medical Devices is significant news. The Platform hits the nail on the head by addressing all of the above mentioned challenges along with reducing time to market.
More information about Wind River Platform for Medical Devices is available here: http://www.windriver.com/announces/platform-for-medical-devices/