Medical Device Software Documentation

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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 … See more

Documentation for Medical Device Software …

https://sunstonepilot.com/2021/08/documentation-for-medical-device-software/

The documentation needed for medical device software is lengthy and complex. Make sure ...

FDA Software Documentation for Medical …

https://www.kolabtree.com/blog/fda-software-documentation-for-medical-devices/

Sep 1, 2020

Software validation documentation for a medical device

https://medicaldeviceacademy.com/software-validation-documentation/

Software hazard analysis is different from traditional device hazard analysis because software hazards are unique to software. A traditional device hazard analysis …

Medical Device Software Architecture Documentation …

https://openregulatory.com/medical-device-software-architecture-documentation-iec-62304/

Medical Device Software Architecture Documentation (IEC 62304) Dr. Oliver Eidel. The IEC 62304 requires you to document your Software Architecture. As always, …

7 Documentation Musts for All Software …

https://www.greenlight.guru/blog/software-device-premarket-submission-documentation

FREE CHECKLIST: Get your printable copy of the 7 essential documents you must include in a premarket submission for SaMD and devices containing software …

FDA and IEC 62304 Software Documentation

https://www.promenadesoftware.com/blog/fda-iec62304-software-documentation

Include programming language, hardware platform, OS, etc. Software Requirement Specification - Specify the functional requirements, performance requirements, interface …

Managing, documenting SOUP & OTS in …

https://medicaldevicehq.com/articles/managing-and-documenting-soup-and-ots-in-medical-device-software/

Jun 24, 2021 | Articles, Medical device software IEC 62304 | 4 comments Documentation is a crucial process in essentially everything you do – it serves …

Documentation for medical device product …

https://medicaldevicehq.com/articles/medical-device-product-development-process/

The source code for the software is also output from the design effort. All the outputs should be maintained using document control. The manufacturer …

Software as Medical Device: Classification …

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 …

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