Assurance Cases Medical Devices

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Introduction of Assurance Case Method and its …

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

Assurance case practices have the potential to reduce regulatory burden. Assurance cases are top down and goal driven approach, which will help both the manufacturers and regulators to take...

PRECISE | Assurance Cases for Medical …

https://precise.seas.upenn.edu/research-projects/assurance-cases-medical-devices

An assurance case addressing safety is called a safety case. A safety case is a structured argument, supported by a body of evidence, that provides a compelling, …

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 …

Towards an Assurance Case Practice for Medical Devices

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

An approach to evaluating claims of safety increasingly used in Europe and elsewhere is the safety assurance case. Much like a legal case, the assurance case lays out an …

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 offers a promising answer to the question of how to streamline processes for FDA reviewers, because it allows them to clearly understand …

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 …

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 …

A Way to Shorten Painful Discussions with Auditors

https://www.johner-institute.com/articles/risk-management-iso-14971/and-more/safety-assurance-cases/

The medical device meets the regulatory requirements. Claim: A statement or assurance about a property of a device, system or subsystem to be demonstrated. Claims usually …

Separating Technological and Clinical Safety Assurance for …

http://arxiv-export3.library.cornell.edu/pdf/2302.07873

This separation seems to be effective in reducing the complexity of the assurance. 2 Proposed Assurance Case Separation for Medical Devices 2.1 Goal Structuring …

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