Medical Device Software Configuration Management

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Configuration management and the IEC 62304 standard

https://medicaldevicehq.com/articles/the-iec-62304-standard-and-configuration-management/

IEC 62304 is an essential standard if you are working with the development of medical device software. In this article, you will get an overview of the scope of this …

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 …

FDA Software Guidances and the IEC 62304 Software …

https://sunstonepilot.com/2018/09/fda-software-guidances-and-the-iec-62304-software-standard/

Configuration Management and Product …

https://www.loganconsulting.com/blog/configuration-management-and-product-configuration-in-the-medical-device-industry/

Choosing the right configuration management system for your medical device …

Software Life Cycle Processes for Medical Devices

https://www.johner-institute.com/articles/software-iec-62304/software-lifecycle/

"For devices that incorporate software or for software that are devices in themselves, the software shall be developed and manufactured in accordance with the state of the art …

Configuration Management for Medical Device | Product …

https://iziel.com/configuration-management/

The configuration management process facilitates orderly management of product information and changes for purposes as to revise capability, improve performance, …

IEC 62304: Medical Device Software LifeCycle Processes

https://medium.com/retina-ai-health-inc/iec-62304-medical-device-software-lifecycle-processes-2b7967577c3f

IEC 62304: Medical Device Software LifeCycle Processes | by Dr Stephen Odaibo | The Blog of RETINA-AI Health, Inc. | Medium 500 Apologies, but something …

Software Configuration Management - an overview

https://www.sciencedirect.com/topics/computer-science/software-configuration-management

It includes four procedures that should be defined for each software project to ensure that a reliable software configuration management process is utilized. The four procedures …

Software Configuration Management Medical Device

https://www.slideserve.com/IZiel/software-configuration-management-medical-device-11805023

Software Configuration Management Medical Device IEC 62304 is an essential standard if you are working with the development of medical device software. …

IoT for Connected Medical Devices: A Comprehensive Guide

https://www.scnsoft.com/healthcare/medical-devices/connected

Conceptualize IoT software for connected medical devices based on your high-level or detailed requirements. Draw up a comprehensive IoT software feature list. Create a …

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