Solution
Cybersecurity for Medical. Inside Polarion. From TARA to FDA Submission.
A vulnerability disclosed after clearance is still your problem, for the life of the device. Nextedy brings TARA, CVSS and STRIDE into Polarion — linked to the risk file and evidence, not frozen in your submission spreadsheet.
Solution
Cybersecurity for Medical. Inside Polarion. From TARA to FDA Submission.
A vulnerability disclosed after clearance is still your problem, for the life of the device. Nextedy brings TARA, CVSS and STRIDE into Polarion — linked to the risk file and evidence, not frozen in your submission spreadsheet.
Solution
Cybersecurity for Medical. Inside Polarion. From TARA to FDA Submission.
A vulnerability disclosed after clearance is still your problem, for the life of the device. Nextedy brings TARA, CVSS and STRIDE into Polarion — linked to the risk file and evidence, not frozen in your submission spreadsheet.
Click to open
Click to open
Click to open
Problem
The Core Question: How Many of Your Security Requirements Are Really Born from Risk?
General Safety-Critical Systems
30–60 %
High-Integrity Systems
60–80 %
Regulated IT/Automation Systems
40–70 %
Cybersecurity Requirements
80–100 %
Threats Don't Wait for Clearance — Your Risk Picture Shouldn't Either
60–80% of requirements come from risk analyses, yet most organizations run them in separate spreadsheets, disconnected from requirements.
Risk, requirements, and verification drift apart; traceability becomes manual; audits turn into fire drills.
Solution
Cybersecurity Risk Management Built for a Threat Landscape That Never Sits Still
Model Threats and Vulnerabilities, Not Just Hazards
Threats, vulnerabilities, assets, security goals, and security controls stay native Polarion Work Items — linked to your device architecture, software, and verification evidence. A threat profile sits next to the asset it targets, not in a separate spreadsheet.
One threat register across the device platform, not one per team
Assets and threats stay linked to the system architecture
Link TARA findings directly to the requirements and controls they justify
Rate Feasibility and Patient Impact as You Type
TARA per IEC 81001-5-1 and AAMI TIR57, in a spreadsheet grid: attack feasibility from time, expertise, and equipment — impact on the same severity scale as your ISO 14971 risk file. The verdict updates in the sheet.
Six guided views — from Identify Threats to Residual Risk
Feasibility from five attack-potential factors
No retraining for security or quality teams
A Security Risk That Reaches the Patient Is a Safety Risk
Safety-related threats link straight to your ISO 14971 hazards — one severity scale, one record. Security, software, and regulatory affairs stop reconciling spreadsheets.
Safety-related threats link to HARA hazards
Impact rated on the same 5-level severity scale
One assessment feeds both risk files
Automate the Path From Disclosure to Mitigation
Integrate cybersecurity risk management with Polarion's workflow engine, enhanced by RISKSHEET, so a disclosed vulnerability moves straight into triage.
Configure guided workflows for risk treatment
Maintain audit trails for every change
Every threat has an owner and a workflow state
Keep Pace With a Threat Landscape That Never Stops Moving
Unlike a hazard closed out in design, a vulnerability can resurface years after clearance. Polarion’s versioning shows how your threat model changed and when — so a judgement made before submission is still defensible.
Track every revision as new threats surface
Baseline assessments, then re-baseline on a new CVE
Compare versions to spot rating changes
Your SBOM Lives Next to Your Risk File
FDA Section 524B makes an SBOM part of your submission. Keep it in the same project as your TARA and hazards — known vulnerabilities assessed, CVE monitoring tied to your cybersecurity plan.
SPDX SBOM with a known-vulnerability assessment
Score disclosed vulnerabilities with CVSS — available as a RISKSHEET template
Assessment documents for IEC 81001-5-1 and AAMI TIR57
Solution
Cybersecurity Risk Management Built for a Threat Landscape That Never Sits Still
Model Threats and Vulnerabilities, Not Just Hazards
Threats, vulnerabilities, assets, security goals, and security controls stay native Polarion Work Items — linked to your device architecture, software, and verification evidence. A threat profile sits next to the asset it targets, not in a separate spreadsheet.
One threat register across the device platform, not one per team
Assets and threats stay linked to the system architecture
Link TARA findings directly to the requirements and controls they justify
Rate Feasibility and Patient Impact as You Type
TARA per IEC 81001-5-1 and AAMI TIR57, in a spreadsheet grid: attack feasibility from time, expertise, and equipment — impact on the same severity scale as your ISO 14971 risk file. The verdict updates in the sheet.
Six guided views — from Identify Threats to Residual Risk
Feasibility from five attack-potential factors
No retraining for security or quality teams
A Security Risk That Reaches the Patient Is a Safety Risk
Safety-related threats link straight to your ISO 14971 hazards — one severity scale, one record. Security, software, and regulatory affairs stop reconciling spreadsheets.
Safety-related threats link to HARA hazards
Impact rated on the same 5-level severity scale
One assessment feeds both risk files
Automate the Path From Disclosure to Mitigation
Integrate cybersecurity risk management with Polarion's workflow engine, enhanced by RISKSHEET, so a disclosed vulnerability moves straight into triage.
Configure guided workflows for risk treatment
Maintain audit trails for every change
Every threat has an owner and a workflow state
Keep Pace With a Threat Landscape That Never Stops Moving
Unlike a hazard closed out in design, a vulnerability can resurface years after clearance. Polarion’s versioning shows how your threat model changed and when — so a judgement made before submission is still defensible.
Track every revision as new threats surface
Baseline assessments, then re-baseline on a new CVE
Compare versions to spot rating changes
Your SBOM Lives Next to Your Risk File
FDA Section 524B makes an SBOM part of your submission. Keep it in the same project as your TARA and hazards — known vulnerabilities assessed, CVE monitoring tied to your cybersecurity plan.
SPDX SBOM with a known-vulnerability assessment
Score disclosed vulnerabilities with CVSS — available as a RISKSHEET template
Assessment documents for IEC 81001-5-1 and AAMI TIR57
Solution
Cybersecurity Risk Management Built for a Threat Landscape That Never Sits Still
Model Threats and Vulnerabilities, Not Just Hazards
Threats, vulnerabilities, assets, security goals, and security controls stay native Polarion Work Items — linked to your device architecture, software, and verification evidence. A threat profile sits next to the asset it targets, not in a separate spreadsheet.
One threat register across the device platform, not one per team
Assets and threats stay linked to the system architecture
Link TARA findings directly to the requirements and controls they justify
Rate Feasibility and Patient Impact as You Type
TARA per IEC 81001-5-1 and AAMI TIR57, in a spreadsheet grid: attack feasibility from time, expertise, and equipment — impact on the same severity scale as your ISO 14971 risk file. The verdict updates in the sheet.
Six guided views — from Identify Threats to Residual Risk
Feasibility from five attack-potential factors
No retraining for security or quality teams
A Security Risk That Reaches the Patient Is a Safety Risk
Safety-related threats link straight to your ISO 14971 hazards — one severity scale, one record. Security, software, and regulatory affairs stop reconciling spreadsheets.
Safety-related threats link to HARA hazards
Impact rated on the same 5-level severity scale
One assessment feeds both risk files
Automate the Path From Disclosure to Mitigation
Integrate cybersecurity risk management with Polarion's workflow engine, enhanced by RISKSHEET, so a disclosed vulnerability moves straight into triage.
Configure guided workflows for risk treatment
Maintain audit trails for every change
Every threat has an owner and a workflow state
Keep Pace With a Threat Landscape That Never Stops Moving
Unlike a hazard closed out in design, a vulnerability can resurface years after clearance. Polarion’s versioning shows how your threat model changed and when — so a judgement made before submission is still defensible.
Track every revision as new threats surface
Baseline assessments, then re-baseline on a new CVE
Compare versions to spot rating changes
Your SBOM Lives Next to Your Risk File
FDA Section 524B makes an SBOM part of your submission. Keep it in the same project as your TARA and hazards — known vulnerabilities assessed, CVE monitoring tied to your cybersecurity plan.
SPDX SBOM with a known-vulnerability assessment
Score disclosed vulnerabilities with CVSS — available as a RISKSHEET template
Assessment documents for IEC 81001-5-1 and AAMI TIR57
AI Assistant Capabilities
AI That Knows an Exploit From a Patient Risk. Engineers Who Stay in Control.
RISKSHEET AI Assistant knows your medical device security ontology — assets, threat scenarios, attack feasibility, patient impact, and the links to your HARA. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing threat scenarios, unmitigated vulnerabilities, or inconsistent risk scores — surfaced in the sheet.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and premarket context.
Commit to Grid
One click applies human-approved content into the security risk record — immediately submission-ready.
AI Assistant Capabilities
AI That Knows an Exploit From a Patient Risk. Engineers Who Stay in Control.
RISKSHEET AI Assistant knows your medical device security ontology — assets, threat scenarios, attack feasibility, patient impact, and the links to your HARA. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing threat scenarios, unmitigated vulnerabilities, or inconsistent risk scores — surfaced in the sheet.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and premarket context.
Commit to Grid
One click applies human-approved content into the security risk record — immediately submission-ready.
AI Assistant Capabilities
AI That Knows an Exploit From a Patient Risk. Engineers Who Stay in Control.
RISKSHEET AI Assistant knows your medical device security ontology — assets, threat scenarios, attack feasibility, patient impact, and the links to your HARA. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing threat scenarios, unmitigated vulnerabilities, or inconsistent risk scores — surfaced in the sheet.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and premarket context.
Commit to Grid
One click applies human-approved content into the security risk record — immediately submission-ready.
Why Nextedy
Our Expertise, Your Advantage
We build native applications that extend Polarion ALM into the workflows it doesn’t cover — purpose-built for automotive, medical device, and aerospace teams. A certified Siemens Solution Partner trusted by 130,000+ licensed users, Nextedy doubles the value of your Polarion investment.
Why Nextedy
Our Expertise, Your Advantage
We build native applications that extend Polarion ALM into the workflows it doesn’t cover — purpose-built for automotive, medical device, and aerospace teams. A certified Siemens Solution Partner trusted by 130,000+ licensed users, Nextedy doubles the value of your Polarion investment.
Why Nextedy
Our Expertise, Your Advantage
We build native applications that extend Polarion ALM into the workflows it doesn’t cover — purpose-built for automotive, medical device, and aerospace teams. A certified Siemens Solution Partner trusted by 130,000+ licensed users, Nextedy doubles the value of your Polarion investment.
Trusted by Industry Leaders
Trusted by Industry Leaders
Trusted by Industry Leaders
Our Customers
Industry Leaders Rely on Nextedy
How Optum Tech Streamlined Test-Case Inventory Management with Nextedy RISKSHEET
How Optum Tech Streamlined Test-Case Inventory Management with Nextedy RISKSHEET
How Optum Tech Streamlined Test-Case Inventory Management with Nextedy RISKSHEET
“At J&J we have been using Nextedy’s software to enhance our Polarion experience, and we couldn’t be more impressed. Their products have proven to be invaluable in improving the functionality and efficiency of our operations.”
Senior Manager
Advanced R&D-Digital Tooling
at Johnson&Johnson MedTech
“At J&J we have been using Nextedy’s software to enhance our Polarion experience, and we couldn’t be more impressed. Their products have proven to be invaluable in improving the functionality and efficiency of our operations.”
Senior Manager
Advanced R&D-Digital Tooling
at Johnson&Johnson MedTech
“At J&J we have been using Nextedy’s software to enhance our Polarion experience, and we couldn’t be more impressed. Their products have proven to be invaluable in improving the functionality and efficiency of our operations.”
Senior Manager
Advanced R&D-Digital Tooling
at Johnson&Johnson MedTech
“At Schaeffler, we have found the Nextedy Apps to be well-integrated with Polarion, offering a seamless and highly cohesive user experience. The products and their tight integration enable efficient and accurate planning within the system and software domains.”
Schaeffler
Armin Graf
“Nextedy GANTT works very smoothly, and working with Nextedy and their support team is always a pleasure.”
Viessmann
Bastian Strauss
“The Nextedy CHECKLIST and GANTT play a vital role in this success — by providing clear structures, reliable planning, and seamless integration into the Polarion engineering environment.”
Arnold NextG
Automotive Supplier
Layers
Native-by-Design Architecture
Unlike competitors relying on integrations, Nextedy delivers a native experience directly on top of the underlying data platform, ensuring a single source of truth.
Familiar Interface. Days to Adopt. Real-Time Data.
Work inside a familiar graphical interface — inline editing, real-time filtering, color-coded formatting — without ever leaving Polarion. Your team adopts it in days, not months.
One Database for all Data. Zero Sync.
Full traceability, audit readiness, and boundary-free reporting.
Security and Privacy by Design.
Built on the platform layer, so your existing Polarion permissions and audit trail apply unchanged.
Your Workflows. Your Data Model.
Works with your existing configuration. Nothing to re-model, nothing to duplicate.
Layers
Native-by-Design Architecture
Unlike competitors relying on integrations, Nextedy delivers a native experience directly on top of the underlying data platform, ensuring a single source of truth.
Familiar Interface. Days to Adopt. Real-Time Data.
Work inside a familiar graphical interface — inline editing, real-time filtering, color-coded formatting — without ever leaving Polarion. Your team adopts it in days, not months.
One Database for all Data. Zero Sync.
Full traceability, audit readiness, and boundary-free reporting.
Security and Privacy by Design.
Built on the platform layer, so your existing Polarion permissions and audit trail apply unchanged.
Structured reviews with accountability.
Configurable checklists linked to work items. Gate your process with reviews that leave an auditable trail.
Layers
Native-by-Design Architecture
Unlike competitors relying on integrations, Nextedy delivers a native experience directly on top of the underlying data platform, ensuring a single source of truth.
Familiar Interface. Days to Adopt. Real-Time Data.
Work inside a familiar graphical interface — inline editing, real-time filtering, color-coded formatting — without ever leaving Polarion. Your team adopts it in days, not months.
One Database for all Data. Zero Sync.
Full traceability, audit readiness, and boundary-free reporting.
Security and Privacy by Design.
Built on the platform layer, so your existing Polarion permissions and audit trail apply unchanged.
Your Workflows. Your Data Model.
Works with your existing configuration. Nothing to re-model, nothing to duplicate.
How Are Products Licensed?
As an annual software subscription. Active users of a given app need a Named Active User license for that product; a Connect license is required per server and gives every Polarion user read-only access to that app's views as a report. A commercial license covers one production instance on one Polarion server, including a load-balanced or multi-node cluster.
How Are Products Licensed?
As an annual software subscription. Active users of a given app need a Named Active User license for that product; a Connect license is required per server and gives every Polarion user read-only access to that app's views as a report. A commercial license covers one production instance on one Polarion server, including a load-balanced or multi-node cluster.
How Are Products Licensed?
As an annual software subscription. Active users of a given app need a Named Active User license for that product; a Connect license is required per server and gives every Polarion user read-only access to that app's views as a report. A commercial license covers one production instance on one Polarion server, including a load-balanced or multi-node cluster.
Functional Safety and Cybersecurity Belong Together
Functional Safety and Cybersecurity Belong Together
Discover Nextedy's functional safety solution for medical devices, on the same RISKSHEET foundation.
Discover Nextedy's functional safety solution for medical devices, on the same RISKSHEET foundation.
