Software Regulations Medical Devices

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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 … 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 FDA issued the Software as a Medical Device: Clinical Evaluation final guidance to describe an internally agreed upon understanding of clinical evaluation and …

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

The international medical device regulators forum (IMDRF), of which the US FDA is a member, describes SaMD as software that may …

General Principles of Software Validation | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

Center for Devices and Radiological Health Center for Biologics Evaluation and Research This guidance outlines general validation principles that the Food and Drug …

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 Medical Device: Classification and Definitions

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

Software as Medical Device: Definitions and Classification Aids With software as medical device, it differentiates between standalone software and software that is part of a medical device. Classifying the …

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. …

IEC 62304 compliance - What are the requirements for …

https://www.tuleap.org/software-quality/iec62304-requirements-medical-device-software-standard

a software embedded in medical devices, a computer software, a smartphone application (such as HealthMap, mobile health applications). NOTE For PC and smartphone software, the IEC 82304 standard comes …

Medical devices: software applications (apps) - GOV.UK

https://www.gov.uk/government/publications/medical-devices-software-applications-apps

Medical devices: software applications (apps) Information on when software applications are considered to be a medical device and how they are …

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