with Tags: fda X
mbakal Tags: electronics complaince regulation fda medical multicore rational iec62304 virtualization ibm product smarter fema 1,712 Visits
When building safety critical software it is very important to build into the steps of your development process a way to show compliance to the relevant standards. For an industry like medical devices this could mean meeting a standard like IEC 62304 which...
ErikaHorrocks Tags: medical-development rational-doors fda iso iec-61508 doors 61508 iec-62304 iec 62304 medical-device iec-standards agile medical-device-compliance international-standards 3,901 Visits
In what ways is medical device development similar to other product development? If you are in a product development role, you will be very aware of the sorts of challenges you face, including: Increased competition Need to sell into global...
from Blog: The Invisible Thread