Leading-edge manufacturers such as DaimlerChrysler, Johnson Controls and General Motors have united the islands of product development and production through carefully crafted systems that connect ...
The term Secure Product Development Framework (SPDF) was introduced by FDA in the draft guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" ...
According to FDA, medical devices are distinguished from other discretely manufactured products because devices are “intended to affect the structure or any function of the body of man.” 1 By contrast ...
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