Medical Software Regulations

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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

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 …

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 connect to an existing device type for purposes of controlling its operation, function, or energy source, and therefore are the focus of the …

Software As a Medical Device: FDA Digital …

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, …

Medical Devices; Medical Device Classification …

https://www.federalregister.gov/documents/2021/04/19/2021-07860/medical-devices-medical-device-classification-regulations-to-conform-to-medical-software-provisions

A medical image storage device is a device that provides electronic storage and retrieval functions for medical images and may employ software, electronic, or …

Policy for Device Software Functions and Mobile …

https://www.fda.gov/media/80958/download

final rule, “Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act” (86 FR 20278) 6

Software development for healthcare: ISO standards, regulation ...

https://www.effectivesoft.com/blog/basics-of-software-development-for-healthcare.html

For instance, software that helps radiologists and clinicians find and diagnose Covid-19 (medical purpose) by analyzing lung damage on the CT scans is software regulated as …

A guide to the essential healthcare IT standards & regulations

https://itrexgroup.com/blog/healthcare-it-standards-and-regulations/

A Guide to the Essential Healthcare IT Standards & Regulations — ITRex Trending → → A guide to the essential healthcare IT standards & regulations By Victoria …

Overview of Device Regulation | FDA

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

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are: Establishment registration, Medical Device …

FDA regulation of medical software - PubMed

https://pubmed.ncbi.nlm.nih.gov/10788227/

Currently the FDA is reviewing its policy on the regulation of computer software in the medical arena. Healthcare practitioners hope that the FDA will take the least possible …

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