Solution
Functional Safety for Medical Devices. Inside Polarion. Audit-Ready by Design.
Your risk file has to describe the device you ship today, not the one you designed. Nextedy brings ISO 14971 risk work into Polarion — hazards, risk controls and evidence on one record, current as the device changes.
Solution
Functional Safety for Medical Devices. Inside Polarion. Audit-Ready by Design.
Your risk file has to describe the device you ship today, not the one you designed. Nextedy brings ISO 14971 risk work into Polarion — hazards, risk controls and evidence on one record, current as the device changes.
Solution
Functional Safety for Medical Devices. Inside Polarion. Audit-Ready by Design.
Your risk file has to describe the device you ship today, not the one you designed. Nextedy brings ISO 14971 risk work into Polarion — hazards, risk controls and evidence on one record, current as the device changes.
Click to open
Click to open
Click to open
Problem
The Core Question: How Many of Your Requirements Are Born from Risk?
General Safety-Critical Systems
30–60 %
High-Integrity Systems
60–80 %
Regulated IT/Automation Systems
40–70 %
Cybersecurity Requirements
80–100 %
Note: while examples are often from MedTech/Pharma due to clear standards, this principle applies broadly across safety-critical domains.
The Work Exists. The Evidence Chain Is Fragile.
Rating drift. The same hazard gets different ratings from different teams. Decisions become hard to defend.
Stale analysis. The design moved on, the risk file did not. It describes an older device.
Late evidence. Before the audit, the chain is rebuilt by hand: hazard → control → requirement → test.
60–80% of requirements come from risk analyses, yet most organizations run them in separate spreadsheets, disconnected from requirements.
Solution
One Engineering Record. From Risk to Evidence.
Requirements, Risks, and Verification — One System.
Risk controls create requirements. Requirements need verification. When risk analysis lives in the same system, the whole chain — hazard → control → requirement → test → residual risk — is linked from the start. Traceability stops being extra work: it’s a column the analyst already sees.
Change impact is computable, not guessed
Verification coverage of risk controls, visible live
Auditors read the record — no rebuilt evidence
Feels Like Excel. Behaves Like a Database.
Analysts think in rows. Auditors think in records. With RISKSHEET you get both: the spreadsheet feel your team knows, where every row is a live Polarion work item — traced, versioned, and permission-controlled. Ratings recalculate as you type, and colors flag the highest risks.
Hierarchical analysis — system → subsystem → component — in one sheet
No retraining for teams coming from Excel
Filter, compare, edit without leaving the engineering record
Every Analysis. One Record. Your Interpretation.
The tool doesn’t prescribe your process — the template does. Run every analysis your file requires — ISO 14971 hazard analysis, design and process FMEA, usability risk (IEC 62366-1), benefit-risk — as connected sheets on the same live Polarion data. Set your own fields, scales, matrices, and workflows.
Shared hazard and harm catalogs — every team rates against the same definitions, on the same scales.
Your scales, your matrices, your formulas — configured, not coded
Extend to new frameworks — SaMD, AI/ML, cybersecurity — the moment your regulators do
A Risk Isn’t Closed When It’s Rated.
A risk is closed when its control, requirement, verification, and residual risk are connected. Each risk control is a live Polarion work item — owned, scheduled, and tracked in the sheet.
From risk to assigned task in one click
Open controls visible in the sheet
Full audit trail on every change
Evidence That Survives Change.
The risk file must stay current as the device changes — design updates, CAPAs, complaints, post-market. Baseline each milestone and see what a change touches.
Answer “what changed?” in minutes
Post-market feedback flows into the record (Clause 10)
Impact follows the chain: risk → requirement → test
The Risk Management File — Generated.
The risk file is read from live engineering data — not rebuilt before the audit. Generate the ISO 14971 report, FMEA workbooks, and traceability matrices on demand.
The file your notified body asks for, on demand
See which system elements lack analysis
Every export current on the day you need it
Solution
One Engineering Record. From Risk to Evidence.
Requirements, Risks, and Verification — One System.
Risk controls create requirements. Requirements need verification. When risk analysis lives in the same system, the whole chain — hazard → control → requirement → test → residual risk — is linked from the start. Traceability stops being extra work: it’s a column the analyst already sees.
Change impact is computable, not guessed
Verification coverage of risk controls, visible live
Auditors read the record — no rebuilt evidence
Feels Like Excel. Behaves Like a Database.
Analysts think in rows. Auditors think in records. With RISKSHEET you get both: the spreadsheet feel your team knows, where every row is a live Polarion work item — traced, versioned, and permission-controlled. Ratings recalculate as you type, and colors flag the highest risks.
Hierarchical analysis — system → subsystem → component — in one sheet
No retraining for teams coming from Excel
Filter, compare, edit without leaving the engineering record
Every Analysis. One Record. Your Interpretation.
The tool doesn’t prescribe your process — the template does. Run every analysis your file requires — ISO 14971 hazard analysis, design and process FMEA, usability risk (IEC 62366-1), benefit-risk — as connected sheets on the same live Polarion data. Set your own fields, scales, matrices, and workflows.
Shared hazard and harm catalogs — every team rates against the same definitions, on the same scales.
Your scales, your matrices, your formulas — configured, not coded
Extend to new frameworks — SaMD, AI/ML, cybersecurity — the moment your regulators do
A Risk Isn’t Closed When It’s Rated.
A risk is closed when its control, requirement, verification, and residual risk are connected. Each risk control is a live Polarion work item — owned, scheduled, and tracked in the sheet.
From risk to assigned task in one click
Open controls visible in the sheet
Full audit trail on every change
Evidence That Survives Change.
The risk file must stay current as the device changes — design updates, CAPAs, complaints, post-market. Baseline each milestone and see what a change touches.
Answer “what changed?” in minutes
Post-market feedback flows into the record (Clause 10)
Impact follows the chain: risk → requirement → test
The Risk Management File — Generated.
The risk file is read from live engineering data — not rebuilt before the audit. Generate the ISO 14971 report, FMEA workbooks, and traceability matrices on demand.
The file your notified body asks for, on demand
See which system elements lack analysis
Every export current on the day you need it
Solution
One Engineering Record. From Risk to Evidence.
Requirements, Risks, and Verification — One System.
Risk controls create requirements. Requirements need verification. When risk analysis lives in the same system, the whole chain — hazard → control → requirement → test → residual risk — is linked from the start. Traceability stops being extra work: it’s a column the analyst already sees.
Change impact is computable, not guessed
Verification coverage of risk controls, visible live
Auditors read the record — no rebuilt evidence
Feels Like Excel. Behaves Like a Database.
Analysts think in rows. Auditors think in records. With RISKSHEET you get both: the spreadsheet feel your team knows, where every row is a live Polarion work item — traced, versioned, and permission-controlled. Ratings recalculate as you type, and colors flag the highest risks.
Hierarchical analysis — system → subsystem → component — in one sheet
No retraining for teams coming from Excel
Filter, compare, edit without leaving the engineering record
Every Analysis. One Record. Your Interpretation.
The tool doesn’t prescribe your process — the template does. Run every analysis your file requires — ISO 14971 hazard analysis, design and process FMEA, usability risk (IEC 62366-1), benefit-risk — as connected sheets on the same live Polarion data. Set your own fields, scales, matrices, and workflows.
Shared hazard and harm catalogs — every team rates against the same definitions, on the same scales.
Your scales, your matrices, your formulas — configured, not coded
Extend to new frameworks — SaMD, AI/ML, cybersecurity — the moment your regulators do
A Risk Isn’t Closed When It’s Rated.
A risk is closed when its control, requirement, verification, and residual risk are connected. Each risk control is a live Polarion work item — owned, scheduled, and tracked in the sheet.
From risk to assigned task in one click
Open controls visible in the sheet
Full audit trail on every change
Evidence That Survives Change.
The risk file must stay current as the device changes — design updates, CAPAs, complaints, post-market. Baseline each milestone and see what a change touches.
Answer “what changed?” in minutes
Post-market feedback flows into the record (Clause 10)
Impact follows the chain: risk → requirement → test
The Risk Management File — Generated.
The risk file is read from live engineering data — not rebuilt before the audit. Generate the ISO 14971 report, FMEA workbooks, and traceability matrices on demand.
The file your notified body asks for, on demand
See which system elements lack analysis
Every export current on the day you need it
AI Assistant Capabilities
AI That Knows a Hazard From a Harm. Engineers Who Stay in Control.
RISKSHEET AI Assistant knows the ISO 14971 ontology — hazards, hazardous situations, harms, risk controls, and residual risk. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing hazardous situations, uncontrolled risks, or inconsistent ratings — surfaced in the sheet.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and your ISO 14971 context.
Commit to Grid
One click applies human-approved content into the risk record — a live link, immediately audit-ready.
AI Assistant Capabilities
AI That Knows a Hazard From a Harm. Engineers Who Stay in Control.
RISKSHEET AI Assistant knows the ISO 14971 ontology — hazards, hazardous situations, harms, risk controls, and residual risk. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing hazardous situations, uncontrolled risks, or inconsistent ratings — surfaced in the sheet.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and your ISO 14971 context.
Commit to Grid
One click applies human-approved content into the risk record — a live link, immediately audit-ready.
AI Assistant Capabilities
AI That Knows a Hazard From a Harm. Engineers Who Stay in Control.
RISKSHEET AI Assistant knows the ISO 14971 ontology — hazards, hazardous situations, harms, risk controls, and residual risk. It proposes; you accept, edit, or reject — and every decision is stored in Polarion. AI does not sign off.
Identify a Gap
Missing hazardous situations, uncontrolled risks, or inconsistent ratings — surfaced in the sheet.
Review Evidence
Every suggestion arrives with its reasoning and sources — project history and your ISO 14971 context.
Commit to Grid
One click applies human-approved content into the risk record — a live link, immediately audit-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
“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
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 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 cybersecurity risk management solution for Polarion
Discover Nextedy’s cybersecurity risk management solution for Polarion
