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Claim
A precise statement of the safety conclusion being supported for a defined product, intended use, users, and environment.
Safety Assurance Cases
Make the safety argument explicit. Connect it to evidence.
A traditional safety assurance case provides a structured, evidence-supported argument that product hazards have been adequately addressed for the intended use and environment. GessNet applies this reasoning discipline to help teams make claims, assumptions, risk controls, and supporting evidence visible and reviewable.
Core structure
Four elements held together deliberately
The method separates what is being claimed, the context in which it applies, the reasoning that supports it, and the evidence offered to substantiate it.
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Context and assumptions
The boundaries, definitions, operating conditions, and assumptions on which the claim depends.
03
Argument
The explicit reasoning showing how hazards were identified, controls were selected, and sub-claims support the top-level conclusion.
04
Evidence
Verification, validation, analysis, and lifecycle information traceable to the argument element it supports.
Why structure matters
Evidence is more persuasive when its purpose is explicit
When safety information is assembled document by document, connections among hazards, controls, assumptions, tests, and conclusions can remain implicit. A structured assurance case makes those connections inspectable and easier to challenge.
Important distinction
A safety assurance case is not a universal regulatory requirement for every medical product. Its use, scope, and regulatory relevance depend on the product, risk context, applicable guidance, and the purpose of the review.
Confidence questions
A practical review of the argument
A case should allow reviewers to answer these questions without relying on unstated assumptions.
01
Is the claim clearly bounded by intended use, users, environment, and product configuration?
Review the supporting rationale and evidence rather than treating completion of a document as the conclusion.
02
Does the argument address the relevant hazards and hazardous situations?
Review the supporting rationale and evidence rather than treating completion of a document as the conclusion.
03
Is the evidence sufficient, current, and traceable to the argument it supports?
Review the supporting rationale and evidence rather than treating completion of a document as the conclusion.
04
Are assumptions and context explicit, justified, and revisited as information changes?
Review the supporting rationale and evidence rather than treating completion of a document as the conclusion.
05
Does the case account for design, manufacturing, use, and post-market lifecycle change?
Review the supporting rationale and evidence rather than treating completion of a document as the conclusion.
06
Are unresolved uncertainties and residual risks visible to accountable decision-makers?
Review the supporting rationale and evidence rather than treating completion of a document as the conclusion.
Connected disciplines
One safety story across analysis, design, and evidence
Assurance reasoning becomes stronger when hazard analysis, FMEA, requirements, design controls, human factors, software, cybersecurity, manufacturing, verification, validation, and lifecycle information are connected rather than treated as separate documentation streams.
QMSpace and TurboAC
TurboAC provides specialized risk-management and assurance-case capabilities. QMSpace extends connected reasoning across broader product-development knowledge, workflow, reuse, and lifecycle information.
Build the argument alongside the product
GessNet can support assurance-case structure, risk analysis, evidence linkage, review, and digital implementation according to the product and regulatory context.