Requirements · Healthcare
FDA postmarket cybersecurity guidance for medical devices
Postmarket Management of Cybersecurity in Medical Devices. 2 Moraph products list it under “Requirements it supports”. The products support this requirement; meeting it remains your organization’s responsibility.
About the rule
What it is
Postmarket Management of Cybersecurity in Medical Devices is guidance from the US Food and Drug Administration, issued in December 2016, on how medical device manufacturers should monitor, identify and address cybersecurity vulnerabilities in devices already on the market. Like other FDA guidance, it sets out the agency’s current thinking rather than binding requirements.
Source: FDA guidance: Postmarket Management of Cybersecurity in Medical Devices. This summary is for orientation only; read the rule itself or ask your counsel for what it requires of you.
Citations
How the products cite it
The exact wording on the product pages, with how many products use each.
- FDA guidance on postmarket management of cybersecurity in medical devices 1 product
- FDA guidance: Postmarket Management of Cybersecurity in Medical Devices 1 product
For what it requires of your organization, read the rule itself or ask your counsel.
Products
The 2 products that support it
IT Service Management
Specialized workflows for Clinical Engineering (e.g., "MRI in Room 4 is down").
Lists:
- FDA guidance on postmarket management of cybersecurity in medical devices
Medical Device Cybersecurity Hub
Inventory of IoMT (Internet of Medical Things) devices, tracking patch status and vulnerabilities.
Lists:
- FDA guidance: Postmarket Management of Cybersecurity in Medical Devices
Not sure which requirements apply to you? Request a gap analysis. All requirements: Requirements our products support.