At Manningham Medical Centre, you can find all the data about Medical Device Software Compliance. We have collected data about general practitioners, medical and surgical specialists, dental, pharmacy and more. Please see the links below for the information you need.
Software as a Medical Device (SaMD) | FDA
- https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
- Given the unique features of Software as a Medical Device that extend beyond a traditional medical device or hardware, regulators across the globe recognized the need to converge on a common framework and principles for Software as a Medical Device that enables all stakeholders, including … See more
Global Approach to Software as a Medical Device | FDA
- https://www.fda.gov/medical-devices/software-medical-device-samd/global-approach-software-medical-device
- The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device Working Group (WG) published a possible risk categorization framework …
Examples of Device Software Functions the FDA Regulates
- https://www.fda.gov/medical-devices/device-software-functions-including-mobile-medical-applications/examples-device-software-functions-fda-regulates
- Software functions (typically mobile apps) that transform a mobile platform into a regulated medical device and therefore are the focus of the FDA's regulatory …
Medical Device Regulatory Compliance …
- https://www.arenasolutions.com/solutions/compliance-management/medical-devices/
- Arena QMS software helps you meet FDA and ISO regulatory compliance. We simplify compliance to FDA …
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