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https://www.fda.gov/MedicalDevices/DigitalHealth/ucm373213.htm 2019 12 3

2 OR.NET e.V.

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2019 31 3

https://www.meti.go.jp/policy/mono_info_service/healthcare/iryou/downloadfil es/pdf/42_guideline.pdf 2019 12 3

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9 Interoperability FDA, Design Considerations and Pre-market Submission Recommen-dations for Interoperable Medical Devices, Sept 6, 2017