Assurance Case Medical Device

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Introduction of Assurance Case Method and its …

https://www.fda.gov/media/125182/download

Assurance Case –An Excellent Tool for Overcoming the Challenge Assurance Case documented body of evidencethat provides a convincing and valid argumentthat a specified set of critical...

Assurance Cases for Medical Devices

https://rtg.cis.upenn.edu/medical/assurance_cases.html

The assurance case is a method for reasoning about systems appropriate for scientists and engineers. An assurance case addressing safety is called a safety case. …

FDA Recognizes Standards for Medical Device …

https://www.raps.org/news-and-articles/news-articles/2019/7/fda-recognizes-standards-for-medical-device-intero

AAMI’s TIR38 serves as a reference to guide the development of assurance cases, which aid in assuring and documenting the safety of medical device designs. …

Infusion Pump Improvement Initiative | FDA

https://www.fda.gov/medical-devices/infusion-pumps/infusion-pump-improvement-initiative

This guidance recommends that manufacturers present this information as a safety assurance case that shows the connection between certain design elements, necessary …

Towards an Assurance Case Practice for Medical Devices

https://resources.sei.cmu.edu/library/asset-view.cfm?assetid=8999

It illustrates the use of the assurance case on a particular type of medical device—the infusion pump. This example serves as a basis for discussing issues surrounding the …

Medical Device Assurance Case - CMD MedTech

https://cmdmedtech.com/wp-content/uploads/2016/04/Medical-Device-Assurance-Case.pdf

One of the identified requirements was the conduct of an assurance case. An assurance case is a “formal method for demonstrating the validity of a claim by providing a …

Separating Technological and Clinical Safety …

https://arxiv.org/pdf/2302.07873

1 day ago · 2 Proposed Assurance Case Separation for Medical Devices 2.1 Goal Structuring Notation In discussion related to assurance cases and in the structure of the …

Safety Assurance Case and FDA - GessNet

https://www.gessnet.com/why-safety-assurance-case

Assurance case (for medical device) is basically an effective communication method to demonstrate assurance of safety, effectiveness and performance. It organizes …

How Safety Assurance Cases Can Improve Your FDA …

https://www.meddeviceonline.com/doc/how-safety-assurance-cases-can-improve-your-fda-submissions-0001

A safety assurance case is a methodology that uses a set of disciplines to structurally demonstrate that a safety claim is fulfilled, and that risk management is a …

FDA Guidance on Infusion Pumps: Safety Assurance Cases

https://www.regdesk.co/fda-guidance-on-infusion-pumps-safety-assurance-cases/

The Agency explicitly mentions that safety cases are device specific and depend on manufacturer-specified design requirements, associated hazards, design …

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