MedTool

Test

ID Name Type UnitIntegrationSystemUsabilitySecurityPrivacy Method Acceptance Criteria Status PlannedIn ProgressBlockedPassedFailed Linked Items (hazards/requirements/controls) Standards Trace Measurements

Measurement

Characteristic Notes

Evidence

ID Name Type ReportLogScreenshotTrace Link / Location Notes

Specification

ID Name Scope Type Assay Step Architecture Element Block Design Choice Interface UI Element Scope Target Parameter Value Type Number Range Enum Text Boolean Value Enum Values (comma) Unit Conditions Source Status draft reviewed approved obsolete Verification Method Evidence Links

Select Source Items

Fault Tree

Description Mark as Top Event Top Event Linked Hazard Linked System Scenarios Rationale / Notes

Select System Scenarios

FTA Node

From (Parent nodes) To (Child nodes) Gate Logic (Event node) AND OR XOR Direction Upward (output top) Downward (output bottom)

Select Nodes

FTA (System) Entry

ID Architecture Element / UI Element Function Guideword Failure modes Possible Causes Hazardous Situation Internal Control DrivenBy

FTA Relationship

Parent (Gate/Event) Child Gate Logic (for Parent) (Keep existing) AND OR XOR

Project Settings

Project Lifecycle Concept Dev V&V PMS E-signature

User Profile

Share Project

Assign existing user Select user… User email Role Viewer Reviewer Contributor Project Admin

Help

Queued Offline Edits

Project Backups

Note (optional)

User Need

ID Name Category Type System TestKit User Need Derived From Derived Verified Method / Acceptance Criteria Verification Evidence

Intended Use

ID Name Description Variant Patient population Clinical environment Operating conditions

Name Description Notes Constraints/Pre-conditions Use Scenario Derived UIS UI Elements

Select Tasks/Steps

Select User Profiles

Add Node

Node Type Task State Action Decision Actor Block UI Element Label

Add Link

Type From To Label Arrow Direction From → To To → From Guard

Use Error

ID Name Scenario Description CategoryPerceptionCognitionAction Safety relevance

Product Requirement

Class Product Requirements Derived From Derived Rationale Satisfied By Verified Method / Acceptance Criteria Verification Evidence

Select User Needs

Select Rationale

Use Error & Hazard Link

Use Error ID Use Scenario Use Error Operational UIS (from Task/Step) Hazard ID Hazard Hazardous Situation Harm Safety Impact Unknown Yes No DrivenBy

New Hazard

ID Name Library Hazard Hazard Origin Standards Trace Hazardous Situations & Sequences Harm Severity12345 Probability12345 Risk control measure Residual risk

Select Library Hazard

Hazard Contexts

Hazard Analysis Entry

Hazard ID Source Sequence of Events Hazardous Situation Risk Control Measures Risk Verification Residual Risk Decision / Notes DrivenBy

Select Source

Residual Risk Decision

Hazard ID Hazard Hazardous Situation Residual Risk Decision Select Accept ALARP - Justified Not Acceptable Justification Approved By Approved On Status Select Proposed Approved Rejected

Risk Control Effectiveness

Risk Control (UIS) Hazards Environment Characteristics Evidence Tests Verification Status Select Planned In Progress Verified Failed Effectiveness Select Effective Partially Effective Ineffective Unknown Residual Risk Notes

PMS Feedback

ID Source Select Complaint CAPA Literature Post-market Surveillance Other Date Description Linked Hazards Linked Controls (UIS) Status Select Open Investigating Closed Trend Select Upward Downward Stable No Trend Notes

Select Items

Convert Asset

Library Item

Type

Import Hazard Library (.xlsx)

Map Excel columns to hazard library fields.

Ingest Standards Text

Standard Split Mode Clause headings Paragraphs Text

Edit Clause

Title Paragraph Intent

Working...

New Asset

Type

Asset Editor

Type ui_element use_scenario arch_element intended_use environment environment_characteristic user_profile hazop_deviation failure_cause material assay_protocol assay_step assay_need system_function hazard requirement ID Name Data (JSON)

Asset

Search

Intended Environment

Template Characteristics

Environment Characteristic

Description Value / Condition Notes

Select Environment Factor Flags

Select Environment Characteristics

Select Environment Characteristics

Search

Select Impact Tags

Select Affected Scenarios

Select Intended Use Scenarios

Template AI Preview

User Profile

ID Name Role User Overview Working Hours Qualification / Training Demographics Use Scenarios Participation

User Task Permissions

Select Use Scenarios

User Characteristic

ID Name Description

Select User Characteristics

UI Characteristics (Safety) Entry

UI Element UI Characteristic Use Scenarios Task/Steps Rationale - Use Error Rationale - Hazards Rationale - Requirement Verification - Test Notes

Select UI Element

Select UI Characteristic

Select Rationale - Requirements

Select Verification Tests

Select Risk Control UIS

Search

Select Risk Verification Tests

Search

Select Use Error

New UI Characteristic

ID (optional) Name Text UI Element Safety related Rationale Type Select type Usability — Use Error Risk — Hazard System — Requirement Rationale — Use Errors Rationale — Hazards Rationale — Requirements

Characteristic

Name Text Rationale Type Select type Usability — Use Error Risk — Hazard System — Requirement Rationale — Use Errors Rationale — Hazards Rationale — Requirements Verification — Tests Verification — Evidence

Select Tests

Select Evidence

New Operating Principle

Statement Notes

Context

Lifecycle State Loss of Assumption Operating Mode Notes

Select System Obligations

Select User Goals

Select Context

Select Items

Select Domains

UIS Entry

ID Name Domain Hardware Software Description DerivedFrom (Requirements) DrivenBy

Stereotype

Description

Select Stereotype

Search

PCA Entry

Use Scenario Task/Step PCA Step Potential Breakdown Use Error Linked UIS UI Interactions (from Use Scenario) Safety Characteristics (from UI) Linked Rationale (from UI Characteristics) Environment Characteristics Safety Impact Yes No

Select Linked UIS

Select Linked Rationale

New Requirement

Statement Derived From Derived Satisfied By Rationale Environment Characteristics Verified Method / Acceptance Criteria Verification Evidence

Select Derived-From Requirements

Search

Select Requirement Rationale

Search

Select Standard Clauses

Select Requirements

Search

Select DrivenBy Assets

Select UI Elements

Select UI Characteristics

Search

Select Existing Characteristics

Select UI Element

Select Blocks

Select Existing Block Characteristics

Select Use Scenarios

Search

Select UIS

Search

Select Materials

Search

Material State

Container / Location Derived From Dry volume is negligible

Import

Upload .xlsx. Column mapping will be requested.

Export

Choose fields and order. Use "All fields" for full export. Move columns with Up/Down.

Assay Need

ID Name Abstract Function Functional Requirement DerivedFrom (Requirements) DrivenBy

Assay Protocol

ID Name Version Status DraftReviewedApprovedObsolete Regime R&DProductionClinicalOther

Assay Stage

ID Name Protocol Sequence External ID Description

Type

Add Property

Property Key Label Type TextNumber

System Function

ID Name Functional Requirement ${(window.state?.assayNeeds || []).map((r) => `${r.displayId || ''} ${r.functionalRequirement || ''}`).join('')} Description Acceptance Criteria Architecture Elements / UI Elements

Select Owners

Add Operation/Reception

Owner Type UI Element Architecture Element Block Owner

HAZOP (Assay)

Guideword LessMoreNotEarlyLateAs well as Deviation Possible Causes Hazardous Situation (Assay Effect) Internal Control DrivenBy

Select Deviation

Select Possible Cause

Search

Add System Failure

Type Assay Deviation (HAZOP) System Failure Failure Cause Guideword Less More No / Not As well as Part of Reverse Other Architecture Element ID Name Text

Design Choice

ID Name Design Domain (optional) Cartridge Instrument Electronics Software Subsystem Select subsystem (UI or Architecture) Decision Type Architecture Component Interface Parameter Status Proposed Approved Deprecated Hazards Description

Select Design Choice

Interface

ID Name From Element From Port To Element To Port Direction Unidirectional Bidirectional Medium (unspecified) Data Control Signal Power Fluid Thermal Mechanical Optical Other Domain (unspecified) Power Data Thermal Fluidic Optical Mechanical Magnetic User Other Status Draft Approved Deprecated Rationale / Integrity Requirements Hazards Driven By

Critical Asset

ID Name Asset Type UI Element Architecture Element Interface Block Asset Criticality (C/I/A) Data Sensitivity Low Medium High PHI PII Rationale

Data Flow Entry

Flow Type Data Class PHI PII Sensitive Operational Other Data Sensitivity Low Medium High Privacy Impact Yes No Security Impact Yes No Notes

Threat Actor

ID Name Category External Insider Partner System Unknown Motivation Capabilities Notes

Vulnerability

ID Name Risk Domain Security Privacy Hybrid Type Design Implementation Configuration Process Supply Chain Unknown Affected Asset Type UI Element Architecture Element Interface Block LINDDUN Categories (comma/semicolon separated) Description Reference Processing Contexts Privacy Rights Mitigation Requirements Evidence Tests Status Draft Reviewed Approved Closed Reviewed By Approved By Approval Date

Threat

ID Name Threat Framework STRIDE PASTA Threat Category Spoofing Tampering Repudiation Information Disclosure Denial of Service Elevation of Privilege Target Type Critical Asset Interface Target CIA Impact Threat Actors Vulnerabilities Mitigation Requirements Evidence Tests Impact Low Medium High Critical Likelihood Low Medium High Attack Surface Risk Mitigation Status Draft Reviewed Approved Closed Reviewed By Approved By Approval Date Notes

DPIA

Threats Vulnerabilities Processing Contexts Risk Rows Requirements Evidence Tests

Select LINDDUN Categories

Select Data Flows

Select Critical Assets

Select Requirements

Select Use Scenarios

Select System Scenarios

Security Risk Entry

Threats Vulnerabilities Mitigation Requirements Evidence Tests Processing Contexts Privacy Rights Privacy Controls DPIA Initial Risk Residual Risk Acceptability Status Open In Progress Mitigated Closed Reviewed By Approved By Approval Date Notes

Select Threats

Select Vulnerabilities

Select Evidence

Select Tests

Select Evidence

Select Tests

Select Evidence

Select Tests

Select Tests

Select Processing Contexts

Select Threats

Select Evidence

Select Threat Actors

Select Vulnerabilities

Select Hazardous Situation

Search

Add Hazardous Situation

ID Name Text Mark as Top Event

Add Possible Cause

ID Name Text

Select Architecture Element

Search

Select Existing Architecture Characteristics

Link Style

Arrow End Start Both None Color

Property

Property Kind Value Constraint Definition Type Value Type Enum Type Struct Type Constraint Block Definition

Operation/Reception

Kind Operation Reception Description Tasks System Scenarios

Select Tasks

Select System Scenarios

Port

Select Hazards

Search Hazards

Chemical Material

ID Name Class SampleReagentBufferWashWasteAirOther Derived FalseTrue Hazard Tags (comma separated) ViscosityLowMediumHighUnknown Foaming RiskLowMediumHighUnknown Temperature SensitivityLowMediumHighUnknown Storage Constraints

FMEA Entry

Failure Mode Cause Local End Effect End Failure Effect Prevention / Mitigation (Cause) Detection Control (Failure Mode) Containment / Recovery Verification Method

Formative Evaluation

ID Name Phase ConceptDevelopmentVerificationValidationPost-Market Verification Method Participants Use Scenarios Use Errors Evidence Tests Use Scenarios / Tasks Findings Decisions Result Status Not RunPassFailInconclusive Result Summary Status PlannedIn ProgressComplete

Summative Evaluation

ID Name Critical Use Scenarios Hazards Risk Controls (UIS) Evidence Tests Protocol Critical Tasks Participants Acceptance Criteria Results Result Status Not RunPassFailInconclusive Result Summary Conclusion Status PlannedIn ProgressComplete

Select Items