Medical Device Regulation Software

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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 regulators, to promote s… See more

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 that are used in active patient monitoring or to analyze patient-specific medical device data and therefore are the focus of the FDA's regulatory …

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 IMDRF Quality Management System for Software as a Medical Device (SaMD) framework helps manufacturers and international regulators attain a common …

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave …

Software As a Medical Device: FDA Digital Health …

https://www2.deloitte.com/us/en/pages/public-sector/articles/software-as-a-medical-device-fda.html

Software As a Medical Device: FDA Digital Health Regulation | Deloitte US Analysis Software as a medical device An …

Download MDR - Medical Device Regulation

https://www.medical-device-regulation.eu/download-mdr/

Download MDR - Medical Device Regulation Download MDR Home / Download MDR Download from the link below the MDR in the main European languages. If you prefer the …

Software as Medical Device: Classification and Definitions

https://www.johner-institute.com/articles/software-iec-62304/software-as-medical-device/

Software that is part of a medical device (often referred to as embedded software) (standalone) software that is an accessory for a medical product such as for forwarding data Standalone software, which is a medical …

Regulatory Challenges with Software as a Medical …

https://www.celegence.com/regulatory-challenges-software-medical-device-mdsw-eu-mdr/

Software that directly controls a medical device (hardware), providing immediate decision-triggering information intended to be used by healthcare professionals or patients (e.g. …

Is your software a Medical Device? - Public Health

https://health.ec.europa.eu/document/download/b865d8e9-081a-4601-a91a-f120321c0491_en

Medical Device Software (MDSW): Software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the …

Medical device software regulations in the EU and US

https://www.raps.org/news-and-articles/news-articles/2023/2/medical-device-software-regulations-in-the-eu-and

Software-based medical devices are integral to healthcare. To enter the marketplace, a company must successfully navigate and comply with applicable national …

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