Functional Safety Risk Management. Inside Polarion. Done Right.
Manage HARA and FMEA processes with full traceability. Compliant with ISO 26262, ISO 14571, and more industry practices.
Set Up Your Proof of Concept – With Your Sample Data
- Validate the fit of Nextedy RISKSHEET while using your actual templates
- Collaborate with our team to tailor templates and workflows
- Experience full traceability, compliance, and user flow inside Polarion
- Start small. Scale when you’re ready.
Please, let us know your name and we get in touch to setup a Proof of concept environment.
“Nextedy has truly exceeded our expectations with their exceptional service and innovative software solutions. “
Senior Manager
Advanced R&D-Digital Tooling
Challenges in Regulated Environments
In functional safety regulated industries, 60–80% of system requirements are risk-driven — yet teams still manage FMEA, HARA, and traceability in disconnected spreadsheets.
The result? Audit headaches, duplicated work, and unsafe products.
PROBLEM
Risk, Requirements & Verifications disconnected
- Excel-based risk sheets lack traceability
- Templates vary across teams, leading to inconsistency
- Linking safety goals to implementation is manual and error-prone
IMPACT
Disconnected tools create silos and inconsistencies.
- Siloed tools: lead to fragmented workflows and miscommunication.
- Compromised Data Integrity: Disconnected requirements, leading to inconsistent data
- Wasted Time: Team members lose up to 12 hours per week searching for scattered data.
SOLUTION
Nextedy RISKSHEET unifies
risk processes
- Centralizes risk data for full traceability within Polarion ALM.
- Automates workflows with pre-made templates to reduce errors and save time.
- Direct links between hazards, safety goals, and implementation artifacts
Capabilities Designed for Functional Safety Engineering
Nextedy RISKSHEET is not just compatible with Polarion—it’s embedded in it. Risk items link directly to requirements, test cases, and documents.
No data exports, no disconnected tools. This ensures a single source of truth across the ALM, accelerating cross-team collaboration and ensuring consistent traceability.
Nextedy RISKSHEET offers a familiar, Excel-inspired interface, reducing training time and driving faster adoption across functional safety, quality, and engineering teams.
No need to sacrifice usability for structure—teams can work as they’re used to, while benefiting from validation, automation, and traceability built in.
Whether you’re working with FMEA (AIAG & VDA), ISO 14971 (medical), ISO 26262 (automotive), or IEC 60812 (reliability), RISKSHEET supports customizable templates that match your internal processes and regulatory requirements.
Predefined fields and scoring systems reduce setup effort while ensuring compliance alignment.
Nextedy RISKSHEET enables you to configure rule-based workflows that guide reviews, approvals, and handoffs.
Automatically notify responsible users, enforce required steps, and maintain audit trails—without relying on manual reminders or extra tools.
Track the evolution of your risk data with built-in versioning. RISKSHEET supports formal baselining and change tracking, allowing you to compare past and present versions, identify deltas, and preserve context for audits and reviews.
Crucial for ensuring transparency and reproducibility in high-stakes environments.
Export structured documentation for Functional Safety Assessments such as risk matrices, FMEA tables, HARA sheets or full audit trails as Excel or PDF.
Whether you’re preparing for an internal review, regulatory inspection, or external stakeholder meeting, RISKSHEET gives you structured, up-to-date outputs that align with industry expectations.
Built for Regulated Development Teams
- Functional Safety Engineers
- Quality Assurance & Compliance Teams
- Project Managers in Automotive & MedTech
- System Architects linking risks to requirements
See Nextedy RISKSHEET in Action:
Full Webinar On-Demand
- How Nextedy RISKSHEET supports FMEA, HARA, and TARA processes inside Polarion
- Real use case of Excel-based risk sheets transformed into structured, auditable models
- Integration tips for linking risk to requirements, test cases, and safety goals
- How to maintain compliance with ISO 26262, ISO 14971, and IEC 60812
- Collaboration workflows across safety, cybersecurity, and QA teams
Evaluate RISKSHEET With a Real Project
Quick and easy way to validate the fit of risk management discipline integrated into Polarion ALM.
Set Up Your Proof of Concept – With Your Sample Data
- Validate the fit of Nextedy RISKSHEET while using your actual templates
- Collaborate with our team to tailor templates and workflows
- Experience full traceability, compliance, and user flow inside Polarion
- Start small. Scale when you’re ready.
Please, let us know your name and we get in touch to setup a Proof of Concept environment.
Convert your Excel Template
We take your current Excel HARA or FMEA templates and convert them into Polarion data models.
Review & Iterate with our Team
Review and provide feedback. After we help you tailor workflows, templates, and interfaces.
Mature your workflow at your pace
Any time, even after the initial rollout, implement catalogs, reusable assets, and model-based approaches.
