The FDA answers cybersecurity questions related to medical devices |

The FDA answers cybersecurity questions related to medical devices

Suzanne Schwartz 2FDA answers cybersecurity questions
(by Joe Hage – Medical Device Marketing Consultant, Medical Devices Group Leader, 10x Medical Device Conference Host)

FDA’s Suzanne Schwartz, MD, MBA, the Director of Emergency Preparedness/Operations and Medical Countermeasures in the Center for Devices and Radiological Health (CDRH), spoke at the 10x Medical Device Conference in San Diego in 2015.




Key Quotes from Suzanne Schwartz:

“Cybersecurity isn’t just a design issue. It’s not just at product launch. It’s a life cycle issue. It requires a change in mindset.”

“At heightened risk are devices with configurable embedded computer systems, plus the challenge of legacy devices.”

“FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity.”

“Stakeholders aren’t really sure how they’re supposed to prioritize vulnerability.”

“What is that value proposition for the C-suite in terms of making early on that careful, intentional effort to make sure our patient-serving devices have better cybersecurity?”

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