Tagged · Labeling

Labeling articles.

Every article in our archive tagged Labeling.

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Showing 2 of 2 articles tagged Labeling

FDA Compliance· Jun 11, 2026

Interoperability Labeling for Connected Medical Devices

What the FDA's Feb 2026 guidance expects in interoperability labeling for connected medical devices, what content goes in user docs, where it sits in eSTAR v7.0, and how to align with IEEE 11073, HL7 FHIR, and DICOM expectations.

#Interoperability #Labeling #HL7 FHIR

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FDA Compliance· Jun 11, 2026

MDS2 / HSCC Disclosure for Medical Devices Explained

What the MDS2 / HSCC Manufacturer Disclosure Statement for Medical Device Security covers, what the FDA's Feb 2026 guidance expects in the disclosure, and where it fits in eSTAR v7.0 labeling.

#MDS2 #HSCC #Labeling

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